Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Aceis on Peritoneal Protein Loss and Solute Transport in pd Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01575652
Recruitment Status : Completed
First Posted : April 11, 2012
Last Update Posted : April 11, 2012
Sponsor:
Information provided by (Responsible Party):
taner basturk, Turkish Nephrology Association

Brief 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.

Condition or disease Intervention/treatment Phase
Disorders Associated With Peritoneal Dialysis Other: Group using angiotensin converting enzyme inhibitor Other: Group not using angiotensin converting enzyme inhibitor Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effects of Angiotensin Converting Enzyme Inhibitors on Peritoneal Protein Loss and Solute Transport in Peritoneal Dialysis Patients
Study Start Date : June 2008
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arm Intervention/treatment
Active Comparator: ACE-I
Group using ACEIs
Other: Group using angiotensin converting enzyme inhibitor
Measurement of peritoneal protein loss level with use of ACEIs
Other Names:
  • Perindopril
  • Lisinopril

No Intervention: ACE-I, 2
group not using ace-i
Other: Group not using angiotensin converting enzyme inhibitor
Measurement of peritoneal protein loss level without usage of ACEIs




Primary Outcome Measures :
  1. degree of peritoneal protein loss [ Time Frame: 6 months ]
    measurement of peritoneal protein loss after 6 months treatment of acei



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01575652


Sponsors and Collaborators
Turkish Nephrology Association
Investigators
Layout table for investigator information
Principal Investigator: taner basturk, MD Sisli Etfal training and Education Hospital
Additional Information:
Publications of Results:
Layout table for additonal information
Responsible Party: taner basturk, Principle Investigator, Turkish Nephrology Association
ClinicalTrials.gov Identifier: NCT01575652    
Other Study ID Numbers: D-11-00212R1
First Posted: April 11, 2012    Key Record Dates
Last Update Posted: April 11, 2012
Last Verified: April 2012
Keywords provided by taner basturk, Turkish Nephrology Association:
peritoneal dialysis
protein losses
Additional relevant MeSH terms:
Layout table for MeSH terms
Lisinopril
Perindopril
Angiotensin-Converting Enzyme Inhibitors
Enzyme Inhibitors
Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Cardiotonic Agents
Protective Agents
Physiological Effects of Drugs