Effect of Diuretics on Fluid Status Control and Residual Renal Function in Peritoneal Dialysis Patients

NCT00936923 | Withdrawn Phase 3 DMC

• 1 other identifier: SYSU-PRGPD-diuretics
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

A prospective, randomized, open-label, stratified, controlled clinical trial to evaluate whether long term furosemide therapy (1 year) would preserve urine volume and/or residual renal function (RRF) and improve fluid state in continuous ambulatory peritoneal dialysis (CAPD) patients.

Conditions

Renal Function Disorder

Keywords

CAPD; Diuretics; Residual Renal Function; furosemide

Outcome Measures

Primary Outcomes (1)

• Residual renal function and urine volume

  Every 3 months

Secondary Outcomes (1)

• Dialysis adequacy, fluid status(BIA parameters: Total body water, ECW/TBW), serum Cystatin C, blood pressure, hospitalization, death from any cause,cardiovascular events, any adverse drug effects

  Every 3 months

Study Arms (3)

furosemide1

ACTIVE COMPARATOR

Patients will take furosemide 60mg per day for 1 years and undergo a study assessment at 3, 6, 12, 18, 24 months .

Drug: furosemide

furosemide 2

ACTIVE COMPARATOR

Patients will take 120mg furosemide per day for 1 years and undergo a study assessment at 3, 6, 12, 18, 24 months .

Drug: furosemide

control

NO INTERVENTION

Patients in control group will not take furosemide

Interventions

furosemide DRUG

patients will take furosemide 60 or 120mg oral per day for 1 years .

Also known as: Lasix(Diuretics)

furosemide 2; furosemide1

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willingness to sign an informed consent
• Age:20\~70 years, regardless of gender
• All patients received CAPD more than 1 months;
• Urine volume of 500ml/d or more;
• No history of taking furosemide for at least 2 weeks .

You may not qualify if:

• Inability or unwillingness to sign the informed consent
• Inability or unwillingness to meet the scheme demands raised by the investigators
• Current acute infection such as peritonitis ;
• Severe diarrhea or vomiting within the preceding 1 month
• Acute Cardiac failure
• Myocardial infarction within the preceding 6 months;
• Hypertensive encephalopathy or cerebrovascular accident;
• Accident within the preceding 6 months;
• Any condition, such as alcohol or drug abuse, chronic liver disease, malignant disease, or psychiatric disorder;
• Allergy or intolerance to furosemide .
• Current or recent (within 2 weeks) exposure to any other investigational drugs

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

The 1st Affiliated Hospital, Sun Yet-sen University

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Interventions

Furosemide

Intervention Hierarchy (Ancestors)

Sulfanilamides; Sulfonamides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sulfones; Sulfur Compounds

Study Officials

• Xueqing Yu, MD,PhD

  Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 9, 2009
• First Posted: July 10, 2009
• Study Start: June 1, 2008
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2012
• Last Updated: May 21, 2015

Record last verified: 2015-05

Locations

CN (1)