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Narasaraopeta Institute of Pharmaceutical Sciences, Narasaraopet, Palnadu, Andhra Pradesh, India. 522601.
Chronic Kidney Disease (CKD) is a progressive and irreversible disease whereby the kidneys' ability to function gradually diminishes until they no longer function at all, resulting in higher morbidity and lower quality of life (QOL). Diabetes Mellitus and Hypertension are the two main risk factors for CKD progression. In addition to this, the acceleration of renal deterioration and increased burden on renal disease can also result from delayed diagnosis, low patient awareness, and lack of effective monitoring of CKD.The goal of this study was to assess the clinical characteristics of CKD, risk factors for CKD prevalence and stage of CKD, and whether structured counseling for CKD patients has a positive effect on the quality of life for patients. Using a prospective observational research design, the CKD samples (N=196) in this study were recruited through questionnaires that provided information about demographic variables, BMI, primary insurance, risk factors for CKD, CKD stage, glomerular filtration rate (GFR), creatinine, diabetes, hypertension, and clinical presentations of CKD.CKD patients' quality of life was measured before and after the CKD patient received structured counseling. To determine the statistical significance of the results, descriptive statistics and chi-square goodness-of-fit tests were used. The results show that the majority of CKD patients in the study were male (60.20%) and presented the majority in the (43-52) year age range (31.12%), with the mean age for all the CKD patients being 51.84 ± 12.74. The patients in this study were primarily of normal BMI (60.71%) but were suffering from both diabetes and hypertension, which accounted for 75% of CKD cases reported in this study..
Kidney disease (CKD) is a chronic illness in which the kidneys can no longer filter the blood effectively due to kidney damage - either from pathology confirmed through imaging studies or renal biopsy, or from other types of abnormalities in urinary sediment, or from an increased albumin level in the urine unless the albumin level is lower than what would be considered "normal" (ACR). This condition will produce a progressive decline in kidney function, ultimately leading to the need for chronic renal replacement therapy (CRT) due to complete loss of kidney function.
The Kidney Disease Improving Global Outcomes (KDIGO) classification system for chronic kidney disease recommends indicating the specific cause for chronic kidney disease and classifying it into 6 stages based on the measured level of glomerular filtration rate (GFR); namely, stages G1 through G5 with stage G3 being further divided into G3a and G3b. In addition, using GFR as an indicator of chronic kidney disease, KDIGO recommends that 3 levels of albuminuria severity be incorporated into the classification for chronic kidney disease A1, A2, and A3 respectively. In staging chronic kidney disease, the clinician is required to measure the albumin-creatinine ratio (ACR mg/g or mg/mmol) in the morning "spot" urine sample for each stage.
The following provides an outline for each the 6 classifications of CKD; stages 1 through 5 (stages 3a and 3b are listed below):
• G1: eGFR ≥ 90 mL/min/1.73m²* and evidence for CKD e.g. hematuria or proteinuria
• G2: eGFR 60-89 mL/min/1.73m²*
• G3a: eGFR 45-59 mL/min/1.73m²
Epidemiology
According to the US CDC / Million Americans Living with Chronic Kidney Disease at an estimate of ~15% of adults on average over the course of time. It's also worth noting approximately 90% of adults do not even know that they have CKD; additionally, 1 out of every 2 individuals whom are not utilizing dialysis and have a very low functioning renal system do not realize that they are afflicted with CKD [NCVI, 2013]. Furthermore, the principal causes for development of CKD amongst adults include diabetic and hypertensive related disorders; furthermore the CDC states that approximately one-third of adults that are diabetic will develop CKD while one-fifth of those whom are hypertensive will develop CKD. In accordance with current CDC statistics, CKD appears to be significantly more prevalent in the greater than or equal to 65 age category (38%) than in the 45 to 64 (13%) or in the 18-44 (7%). Furthermore, CKD occurs slightly more commonly in women (15%) than in their male counterparts (12%); additionally, African American individuals are 3x more likely to develop End Stage Renal Disease (ESRD) when compared to their Caucasian counterparts [NCVI, 2013].
Etiology
Although causes for CKD differ around the world, the most frequently reported primary diseases leading to CKD and eventually to ESRD are: [StatPearls, 2016]
• Diabetes Mellitus Type 2 (30%-50%)
• Diabetes Mellitus Type 1 (3.9%)
• Hypertension (27.2%)
• Primary Glomerulonephritis (8.2%)
• Chronic Tubulointerstitial Nephritis (3.6%)
• Inherited/Cystic Disorders (3.1%)
• Secondary Glomerulonephritis/Vasculitis (2.1%)
• Plasma Cell Dyscrasias/Neoplasms (2.1%)
• Sickle Cell Nephropathy which accounts for less than 1% among ESRD patients in America. For additional information and associated publications, please refer to StatPearls’ associated publication titled “Sickle Cell Disease and its Impact on ESRD”.
Pathophysiology:
Clinical Manifestations:
Individuals may not experience signs or symptoms until the later stages of CKD (stages 4 and 5). The following are frequently cited signs and symptoms at this phase of CKD:
- Nausea
- Vomiting
- Loss of appetite (anorexia)
- Fatigue/weakness
- Difficulty sleeping (insomnia)
- Oliguria
- Decreased mental sharpness (cognitive impairment)
- Muscle spasms/cramps
- Swelling of feet and ankles (peripheral edema)
- Itching/itchy skin (pruritus)
- Chest pain from uremic pericarditis (inflammation of the lining around the heart)
- Shortness of breath from fluid accumulation in the lungs (pulmonary edema)
- High blood pressure ( hypertension)
In terms of examining the body for the patient’s clinical signs, the physical examination may not add valuable information; however, some examples of the physical signs the health-care provider may observe during examination include:
- Colour changes in skin (skin pigmentation changes)
- Scratch marks ( abrasions) from pruritus ( itching)
- Presence of a pericardial friction rub (means there is rubbing/ irritation on the lining surrounding the heart) from uremic pericarditis.
- Uremic frost where high blood urea nitrogen ( BUN) levels cause the urea in sweat to crystallize into fine, white powder form on the skin.
- Hyperreflexia (increased reflexes) and/or tremors ( muscle twitching)
- Hypertensive fundal changes, indicating a chronic process.
Factor's risk that lead to chronic kidney disease progression
The CKD non-modifiable risk factors include being older, male, and belonging to a non-white ethnic group, including black American, Afro-Caribbean, Hispanic, and Asian (South Asians and Pacific Asian).
Poor genetic determinants for renal disease progression have also been identified in people with renal diseases. A population-based cohort study found that single nucleotide polymorphisms in the TCF7L2 and MTHFS genes are associated with diabetic nephropathy and CKD progression. This same study provided evidence for the existence of polymorphisms in the genes responsible for renal scarring as well as for the RAAS, and the influence of these polymorphisms on CKD progression.
The CKD modifiable risk factors consist of hypertension, proteinuria, and metabolic conditions. Systemic hypertension represents a major cause of ESRD worldwide and is the second most common cause in the United States after diabetes. The transmission of systemic hypertension to the glomerular capillaries is thought to contribute to the glomerular hypertension that leads to the progressive development of glomerulosclerosis. Nighttime and 24-hour BP measurements (e.g., ABPM) correlate more closely with CKD progression than do standard BP measurements. In particular, systolic BP has been shown to be the main predictor of CKD progression and is associated with the complications of CKD.
Diagnosis
Current theoretical diagnostic indicators by which to assess CKD from a clinical perspective include; serum creatinine, glomerular filtration rate, and proteinuria. The serum creatinine infers change from the volume of creatine (by product of muscle metabolism), through its relationship to how much is excreted from our body, therefore make it a primary parameter for diagnosing CKD. However, creatinine has an overwhelming number of measurement errors associated with it, (due to interference from numerous physical and biochemical factors, poor specificity and wide variation). Also, creatinine is not a disease specific marker of CKD and is impacted by such markers as muscle mass, muscle composition, protein intake in one's diet, medication taken in diet, etc., therefore also causing imprecision in determining one's GFR. In addition, creatinine does not correlate with the presence of co-morbidities [46]. Furthermore, the association of muscle mass to creatinine can lead to the same creatinine values for patients with different GFRs and results in CKD diagnosis being falsely positive. Also, about half of GFR must be lost before creatinine level from a lab test is abnormal and; this is when 3rd stage of CKD is diagnosed. Due to the inverse relation of GFR to creatinine, any large reduction in a person's GFR will only lead to small increases in the level of serum from the laboratory (due to creatinine); therefore, because the amount of time between CKD diagnosis and creatinine test and the treatment of CKD will be substantial, if a person has only renal function loss but has no effect yet on creatinine they may be considered to have a normal creatinine level, despite the continued sodal incidence of deterioration of the kidney's ability to function.
Management of cardiovascular disease risk
The incidence and prevalence of cardiovascular disease (CVD) are greater in patients with chronic kidney disease (CKD) than in patients without CKD. In a Medicare 5% sample of 175,840 adults aged 66 years and over with CKD, the percentage with CVD was significantly higher than for those without CKD; for example, 65% of patients with CKD versus 32% of patients without CKD had at least one type of CVD [63]. In addition, having a diagnosis of CKD is associated with lower cardiovascular outcomes. In the same study, for people with CKD and coronary artery disease, the survival rate at 2 years was lower (77% vs. 87%) than for people without CKD; the same is true for those with acute myocardial infarction (69% vs. 82%), heart failure (65% vs. 76%), atrial fibrillation (70% vs. 83%), and cerebrovascular accident/transient ischemic attack (73% vs. 83%) [63], all of which demonstrate the increased CVD risk in individuals with CKD.
Thus, a key component of managing CKD is decreasing cardiovascular risk. For patients aged 50 years or older with CKD, it has been recommended that they be treated with low-to-moderate-dose statins regardless of low-density lipoprotein (LDL) cholesterol level [64][65][66]. Smoking cessation is also an important consideration [67][68]. Both the Eighth Joint National Committee (JNC 8) and Kidney Disease: Improving Global Outcomes (KDIGO) recommend that the systolic and diastolic blood pressure of adults with CKD be <140 mmHg and <90 mmHg, respectively, based on expert opinion [67][69]. The KDIGO guideline also recommends that patients.
Dietary Management:
The idea of using dietary management to stop CKD from becoming worse is highly debated due to the vast number of trials that do not have clear and conclusive results regarding this approach [102-104]. The MDRD study showed insignificant or conflicting results when comparing the two different levels of protein restriction (2 types of low-protein diet) for 840 patients enrolled in this study. While there was an indication of a low-protein diet leading to a slower decline in GFR after the first 4 months of beginning the low-protein diet compared to the regular-protein intake diet (used in the study), there was no evidence of a very low-protein diet leading to a slower decline in GFR compared to a low-protein diet. Patients who developed proteinuria (>3 gm urine protein/day) did show some benefit by being on a low-protein diet (but this group of patients was not large enough to provide a conclusion) [102]. Some smaller trials do suggest that there may be some benefit from protein restriction in preventing CKD progression/ESKD [105-107]. The KDIGO Guidelines recommend that patients with CKD Stage G4-G5 reduce their protein intake to less than 0.8 gm/kg of body weight/day (after adequate nutrition education) and that other adult patients with CKD who are at risk for CKD progression reduce their protein intake to less than 1.3 gm/kg of body weight/day [67]. The potential benefits associated with dietary protein restriction are often weighed against the potential side effects associated with malnutrition and/or protein-wasting syndrome seen as a result of implementing a protein-restricted diet [67][102][103][108]. Decreasing dietary acid load (ie, increasing intake of fruits and vegetables and decreasing intake of animal-based foods such as meat, eggs, and cheese) may also reduce the risk of kidney injury.
Study site:
Kosuru Kidney and Skin hospital at Narasaraopet.
Study design:
A hospital-based prospective Observational study.
Study period:
The study was conducted for a period of 6 months.
Sample size:
Based on N- Masters formula considering a 95% confidence level, 5% margin of error and the minimum required sample size for our study is 196.
Materials:
Study criteria:
The study will be carried out by considering the following criteria:
Inclusion criteria:
Exclusion criteria:
Ethical approval:
This study was approved by the Institutional Ethics Committee of Narasaraopeta Institute of Pharmaceutical Sciences, Narasaraopeta.
IEC-NIPS/PPP/2025-26/006
Study procedure:
The purpose of this study was to determine the number of individuals diagnosed with chronic kidney disease who come to the nephrology department. To determine this, all patients with CKD were assessed for their prevalence, risk factors, and how long they have had CKD by looking at their creatinine levels and glomerular filtration rates. To be eligible for inclusion in the study, patients had to meet all study inclusion criteria. To collect information on the participants, a specific data collection sheet will be created.
Demographic information includes name, age, sex, height, weight, and clinical data will include chief complaint(s), date of symptom onset, previous medical history, medications taken, laboratory investigations performed, diagnosis(es) made, and overall status of the subject. Clinical data will be obtained from medical record review and/or by interviewing the participant.
RESULTS
1.Distribution based on age:
|
AGE (Years) |
NO.OF PATIENTS |
PERCENTAGE (%) |
|
23-32 |
14 |
7.14 |
|
33-42 |
30 |
15.31 |
|
43-52 |
61 |
31.12 |
|
53-62 |
49 |
25.00 |
|
63-72 |
33 |
16.84 |
|
73-82 |
8 |
4.08 |
|
83-92 |
1 |
0.51 |
|
Grand Total |
196 |
100.00 |
2.Distribution based on gender:
|
GENDER |
NO.OF PATIENTS |
PERCENTAGE % |
|
FEMALE |
78 |
39.80 |
|
MALE |
118 |
60.20 |
|
Grand Total |
196 |
100.00 |
3.Distribution based on BMI:
|
BMI |
NO.OF PATIENTS |
PERCENTAGE % |
|
NORMAL |
119 |
60.71 |
|
OBESE |
4 |
2.04 |
|
OBESE CLASS I |
7 |
3.57 |
|
OBESE CLASS III |
3 |
1.53 |
|
OVER WEIGHT |
50 |
25.51 |
|
UNDER WEIGHT |
13 |
6.63 |
|
Grand Total |
196 |
100.00 |
4.Distribution based on risk factors:
|
RISK FACTORS |
NO OF PATIENTS |
PERCENTAGE % |
|
CELLULITIS |
2 |
1.02 |
|
DM |
46 |
23.47 |
|
DM,ALD |
1 |
0.51 |
|
DM,ASTHMA |
2 |
1.02 |
|
DM,CELLULITIS |
1 |
0.51 |
|
DM,COPD |
1 |
0.51 |
|
DM,RENAL CALCULI |
3 |
1.53 |
|
DM,SMOKING |
2 |
1.02 |
|
DM,UTI |
12 |
6.12 |
|
HTN |
30 |
15.31 |
|
HTN,ALCOHOLIC |
4 |
2.04 |
|
HTN,CELLULITIS |
2 |
1.02 |
|
HTN,DM |
58 |
29.59 |
|
HTN,DM,COPD |
1 |
0.51 |
|
HTN,DM,RENAL CALCULI |
2 |
1.02 |
|
HTN,DM,SMOKING,ALCOHOLIC |
7 |
3.57 |
|
HTN,DM,UTI |
2 |
1.02 |
|
HTN,POISONING |
1 |
0.51 |
|
HTN,RENAL CALCULI |
1 |
0.51 |
|
HTN,UTI |
5 |
2.55 |
|
NIL |
1 |
0.51 |
|
SEIZURES |
1 |
0.51 |
|
SMOKING |
2 |
1.02 |
|
SMOKING,ALCOHOLIC |
9 |
4.59 |
|
Grand Total |
196 |
100.00 |
5. Distribution based on CKD stages:
|
STAGES |
NO OF PATIENTS |
PERCENTAGE % |
|
1 |
13 |
6.63 |
|
2 |
23 |
11.73 |
|
4 |
53 |
27.04 |
|
5 |
62 |
31.63 |
|
3A |
17 |
8.67 |
|
3B |
28 |
14.29 |
|
Grand Total |
196 |
100.00 |
6. Distribution of diabetes among CKD patients:
|
DIABETES |
NO OF PATIENTS |
PERCENTAGE % |
|
CONTROLLED |
20 |
10.20 |
|
NIL |
57 |
29.08 |
|
UNCONTROLLED |
119 |
60.71 |
|
Grand Total |
196 |
100.00 |
7. Distribution of hypertension among CKD patients:
|
HYPERTENSION |
NO OF PATIENTS |
PERCENTAGE % |
|
CONTROLLED |
25 |
12.76 |
|
NIL |
83 |
42.35 |
|
UNCONTROLLED |
88 |
44.90 |
|
Grand Total |
196 |
100.00 |
8. Distribution based on GFR:
|
GFR |
NO OF PATIENTS |
PERCENTAGE % |
|
3-13 |
47 |
23.98 |
|
13-23 |
35 |
17.86 |
|
23-33 |
38 |
19.39 |
|
33-43 |
17 |
8.67 |
|
43-53 |
21 |
10.71 |
|
53-63 |
3 |
1.53 |
|
63-73 |
6 |
3.06 |
|
73-83 |
16 |
8.16 |
|
83-93 |
13 |
6.63 |
|
Grand Total |
196 |
100.00 |
9. Distribution based on serum creatinine:
|
Sr. CREATININE (mg/dl) |
NO.OF PATIENTS |
PERCENTAGE (%) |
|
0.5-5.5 |
154 |
78.57 |
|
5.5-10.5 |
36 |
18.37 |
|
10.5-15.5 |
6 |
3.06 |
|
Grand Total |
196 |
100.00 |
10. Distribution based on signs and symptoms:
|
SIGNS AND SYMPTOMS |
NO.OF PATIENTS |
PERCENTAGE (%) |
|
ANURIA |
1 |
0.51 |
|
GLYCOSURIA |
9 |
4.59 |
|
HEMATURIA |
13 |
6.63 |
|
HEMATURIA,ALBUMINURIA |
2 |
1.02 |
|
HEMATURIA,ANURIA |
2 |
1.02 |
|
HEMATURIA,GLYCOSURIA |
6 |
3.06 |
|
HEMATURIA,OLIGURIA |
18 |
9.18 |
|
HEMATURIA,PYURIA |
2 |
1.02 |
|
NAUSEA,EDEMA |
7 |
3.57 |
|
NAUSEA,FATIGUE,FEVER |
34 |
17.35 |
|
OLIGURIA |
32 |
16.3 |
|
OLIGURIA,ANURIA |
1 |
0.51 |
|
OLIGURIA,EDEMA |
24 |
12.24 |
|
OLIGURIA,FACIAL PUFFINESS |
1 |
0.51 |
|
OLIGURIA,GLYCOSURIA |
1 |
0.51 |
|
OLIGURIA,NAUSEA |
7 |
3.57 |
|
OLIGURIA,NAUSEA,FEVER |
2 |
1.02 |
|
OLIGURIA,PYURIA |
9 |
4.59 |
|
PEDAL EDEMA |
2 |
1.02 |
|
PROTEINURIA,ALBUMINURIA |
13 |
6.63 |
|
PYURIA |
10 |
5.10 |
|
Grand Total |
196 |
100.00 |
11. QOL scale before counselling:
|
SCORE |
NO OF PATIENTS |
PERCENTAGE % |
|
FAIR |
50 |
25.51 |
|
GOOD |
18 |
9.18 |
|
POOR |
85 |
43.37 |
|
VERY POOR |
43 |
21.94 |
|
Grand Total |
196 |
100.00 |
12. QOL scale after counselling:
|
SCORE |
NO OF PATIENTS |
PERCENTAGE % |
|
EXCELLENT |
22 |
11.22 |
|
FAIR |
75 |
38.27 |
|
GOOD |
70 |
35.71 |
|
POOR |
27 |
13.78 |
|
VERY POOR |
2 |
1.02 |
|
Grand Total |
196 |
100.00 |
DISCUSSION
In this study, we evaluated 196 patients with a diagnosis of chronic kidney disease (CKD) to evaluate the demographic characteristics of the patients, identify symptoms and patterns of CKD, provide information on risk factors associated with CKD, evaluate the effect of counselling on patients' quality of life (QOL) and describe how CKD is distributed geographically, progresses and is treated. The results of this study provide valuable information on how CKD is distributed, its clinical profile, progression and management outcomes.
The distribution of patients by age was as follows; 31.12% of patients belonged to the age group of 43-52 years, and 25.00% to the age group of 53-62 years. The mean age of patients was 51.84 ± 12.74 years. The majority of CKD patients are in the middle age range, presumably due to the impact of risk factors, such as diabetes and hypertension, lifestyle issues (e.g., lack of exercise), occupational stress, and delay in diagnosis. CKD generally follows a progressive course, and therefore, metabolic abnormalities that begin in childhood or early adulthood may be evidenced by changes in kidney function in middle-aged adults. With an overall statistically-significant difference (p < 0.001), the prevalence rate of CKD increases as age increases and is not evenly distributed by age.
On average, there were more males (60.20%) than females (39.80%) with a diagnosis of CKD. A number of reasons have been postulated for this difference in the male-female CKD ratio. For example, the rate of smoking, alcohol consumption, occupational stress and inadequate health seeking behaviour is significantly higher among males than among females. The presence of oestrogen in women's bodies until the time of menopause may also protect the kidneys of females from early damage and/or enhance their ability to obtain medical attention. In many societies, male and female gender roles will influence the pattern of hospital attendance.
CONCLUSION
The current research indicates that chronic kidney disease (CKD) primarily affects individuals in their middle years of life and occurs more often among men than women. In this study, it is obvious that diabetes mellitus and hypertension—alone or in combination—are the main contributing risk factors for the onset and worsening of CKD. Many patients in this study were diagnosed with advanced-stage CKD (stages 4 and/or 5), which means that CKD was not diagnosed in a timely manner; many patients had their CKD diagnosed late due to inadequate monitoring of their progression and/or lack of control over their other medical conditions.
In addition, this study showed that most of the patients who were studied had a low level of glomerular filtration rate (GFR), including a range of serum creatinine levels that indicated significant kidney damage at the time of diagnosis and treatment. Clinical findings such as oliguria, nausea, tiredness, and swelling from edema were common among the study participants and demonstrated that advanced kidneys affect all body systems.
Finally, the research revealed that most study subjects had a low initial quality of life (QOL) as a result of their CKD diagnosis and treatment. However, following counselling by their clinical pharmacist, there was considerable improvement in the patients’ quality of life (with a significant number of patients moving into fair and good quality of life categories). This illustrates the important role that clinical pharmacists play in patient counselling to help improve patient education, encourage patients to take and continue to take their medications, make patients aware of the potential effect of lifestyle choices on their health, and improve a patient’s overall quality of life.
In conclusion, patients at increased risk for developing CKD should be screened for CKD early, have their diabetes and blood pressure tightly controlled, and have their CKD regularly monitored.
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