The effects of oral sodium bicarbonate on extracellular water in patients with chronic renal failure - Sodium bicarbonate use in renal patients

Phase 1

• Conditions: We will investiagte the use of sodium bicarbonate on extracellular water in patients with CHRONIC RENAL FAILURE

• Registration Number: EUCTR2006-002770-22-GB
• Lead Sponsor: York Hospital NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-09-18
• Study Completion: 2011-11-21
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Patients with chronic renal failure defined as stage 3-5 CKD (an estimated glomerular filtration rate (MDRD GFR) of <60 ml/min). Using a serum creatinine >180 µmol/l will mean that nearly all subjects will actually have stage 4/5 CKD (MDRD GFR <30 ml/min).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients on dialysis; already on sodium bicarbonate; poorly controlled hypertension (systolic BP > 160 mmHg; diastolic BP > 90 mmHg); peripheral oedema on clinical assessment; active nephrotic syndrome; history of congestive cardiac failure and/or pulmonary oedema.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: This is a double blind placebo controlled trial of oral sodium bicarbonate against placebo in patients with chronic renal failure. The aim of the trial is to determine the effects of oral sodium bicarbonate on extracellular fluid volumes and blood pressure in patients with renal failure.;Secondary Objective: To determine whether or not biometric impedence monitoring will detect changes demonstrated by gold standard techniques of body water measurements.;Primary end point(s): Change in the ratio Vecf/Vtbw<br>Change in body weight/blood pressure. Agreement between gold standard and bioimpedance measurements of Vecf/Vtbw.