Effects of Aceis on Peritoneal Protein Loss and Solute Transport in pd Patients
Information source: Turkish Nephrology Association
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Disorders Associated With Peritoneal Dialysis
Intervention: Group using angiotensin converting enzyme inhibitor (Other); Group not using angiotensin converting enzyme inhibitor (Other)
Phase: Phase 4
Status: Completed
Sponsored by: Turkish Nephrology Association Official(s) and/or principal investigator(s): taner basturk, MD, Principal Investigator, Affiliation: Sisli Etfal training and Education Hospital
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.
Clinical Details
Official title: Effects of Angiotensin Converting Enzyme Inhibitors on Peritoneal Protein Loss and Solute Transport in Peritoneal Dialysis Patients
Study design: Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: degree of peritoneal protein loss
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- chronic peritoneal dialysis First paragraph.
- 18- 55 years
- no antihypertensive drug usage prior 12 months
Exclusion Criteria:
- usage of antihypertensives prior 12 months
- intolerance to the ace-i
- CAPD related peritonitis prior 6 months or during the study time
- history of malignant hypertension or hypertensive encephalopathy or
cerebrovascular accident within the 6 months prior to the study
- chronic liver diseases
- recent acute illness and/or history of any overt chronic inflammatory disease
Locations and Contacts
Additional Information
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Starting date: June 2008
Last updated: April 10, 2012
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