Effects of Aceis on Peritoneal Protein Loss and Solute Transport in pd Patients
Condition: Disorders Associated With Peritoneal Dialysis
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this study was to examine the effects of angiotensin converting enzyme
      inhibitors on peritoneal membrane transport, peritoneal protein loss, and proteinuria in
      peritoneal dialysis patients.
    

Detailed description: 
      This prospective cohort study was conducted at the Unit of Nephrology of Sisli Etfal
      Education and Research Hospital, Istanbul, Turkey. Prior to subject recruitment, the study
      protocol was reviewed and approved by the local ethics committee, in accordance with the
      ethical principles for human investigations, and written informed consents were obtained from
      all patients. Between june 2008 and january 2009, 54 age and gender matched continuous
      ambulatory peritoneal dialysis (CAPD) patients were included in the study consecutively.

      Patients were divided into 2 groups according to decision of the physician; group 1 (n=34)
      was consisted of patients treated with ACE-Is and group 2 (n=30) was not treated with ACEs.
      The inclusion criteria were chronic PD patients between 18 and 85 years who had not received
      any antihypertensive drugs within prior 12 months. All patients were on standard CAPD program
      (2-2.5 L; 4 exchanges/day). Icodextrin is not used. The exclusion criteria were as follows;
      patients who had a history of antihypertensive treatment with ACE-Is or angiotensin-receptor
      blockers or aldosterone antagonists for prior 12 months from the study time; intolerance to
      the ACE-Is; CAPD-related peritonitis within 6 months prior to or during the study period;
      history of malignant hypertension or hypertensive encephalopathy or cerebrovascular accident
      within the 6 months prior to the study; chronic liver diseases, and recent acute illness
      and/or history of any overt chronic inflammatory disease.

      Demographic variables including etiology of CKD, age, and gender were obtained from patients'
      clinic charts. All blood samples were taken after 10 hours of overnight fasting. Serum urea,
      creatinine, and albumin levels were analyzed. Creatinine clearance [(CCr) dialysate, urine,
      and total], Kt/V (dialysate, urine, and total) were calculated weekly. Daily volumes (UF),
      24-hour protein, and albumin losses (dialysate, urine) were recorded also. Parameters at the
      beginning of study and at the end of 6th month were evaluated. During the study, the dialysis
      regime remained same in all patients. In both groups, investigators analyzed blood, 24-hour
      urine (in patients with residual diuresis >100mL daily), peritoneal effluent fluid at 4
      hours' and 24 hours' dwell time. Peritoneal effluent fluid at 24 hours' dwell time was used
      to determine total protein, albumin, and at 24 hours' dwell time to determine urea and
      creatinine. The urea kinetic test in closest time proximity to the PET was used in the
      analysis.

      After the subject had rested in the supine position for at least 15 minutes blood pressure
      was measured with a standard mercury sphyngomanometer for the three times with the half of a
      cuff around the right arm. Patients' blood pressure measurements were performed on a regular
      basis every month. The mean values were calculated. All patients received standard
      35-cal/kg/day carbohydrate, 1-2 g/kg/day protein, and salt restricted diet. Patients did not
      use essential amino acid and peritoneal dialysis solutions containing amino acids. Serum
      urea, creatinine, and albumin levels were assessed by enzymatic colorimetric assay. Dialysate
      adequacy (Kt/V urea: dialysis and residual), and peritoneal transport (4-hour D/PCr) were
      measured using standard procedures (PD Adequest 1.4, 1994: Baxter Healthcare Corporation,
      Deerfield, IL, U.S.A.). Dialysate albumin loss was measured with the Bromo Cresol Green (BCG)
      method. Dialysate total protein loss was measured by the Biuret method. Urine protein
      concentration was determined by an immunoturbidimetric method.

      Statistical analysis was carried out using the SPSS 13.0 software package (SPSS Inc, Chicago,
      IL, USA). Kolmogorov-Smirnov tests were used to test the normality of data distribution. Data
      were expressed as arithmetic means and standard deviations. Chi-square test was used to
      compare the categorical variables between groups. Independent sample T-test and Mann-Whitney
      U tests were used respectively between groups in normally and abnormally distributed
      continuous variables. Paired t-test and Wilcoxon signed-rank tests were used to analyze
      changes within each group. Two-sided p value <0.05 was considered statistically significant.
    

Intervention name(s): Group using angiotensin converting enzyme inhibitor; Group not using angiotensin converting enzyme inhibitor
Intervention type(s): Other; Other
Intervention description(s): Measurement of peritoneal protein loss level with use of ACEIs; Measurement of peritoneal protein loss level without usage of ACEIs
Other intervention name(s): Perindopril; Lisinopril
Intervention MeSH terms: Lisinopril; Perindopril; Angiotensin-Converting Enzyme Inhibitors; Enzyme Inhibitors
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: peritoneal dialysis; protein losses