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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-002770-22-GB

Enrollment

Registered

2006-09-18

Start date

2006-09-26

Completion date

Unknown

Last updated

2020-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Product Name: sodium bicarbonate Pharmaceutical Form: Capsule* CAS Number: 144-55-8 Current Sponsor code: SOB06 Other descriptive name: Sodium Bicarbonate Concentration unit: mg milligram(s) Concentra

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with chronic renal failure defined as stage 3-5 CKD (an estimated glomerular filtration rate (MDRD GFR) of 180 µmol/l will mean that nearly all subjects will actually have stage 4/5 CKD (MDRD GFR =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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 Change in body weight/blood pressure. Agreement between gold standard and bioimpedance measurements of Vecf/Vtbw.	—

Measure

Time frame

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 Change in body weight/blood pressure. Agreement between gold standard and bioimpedance measurements of Vecf/Vtbw.

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026