Sodium Bicarbonate for Critically Ill Patients With Metabolic Acidosis and Acute Kidney Injury

Sponsor
Universität Münster
Study ID
NCT07464431
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Acute Kidney Injury
  • Critical Illness
  • Metabolic Acidosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sodium Bicarbonate 8.4% Solution for Injection — DRUG
    Intravenous infusion according to the treatment algorithm. Infusion starts with 100ml/hr until a pH of 7.30 - 7.35 and a Base Excess of ≥ 0 is reached. Then, infusion is reduced to 25ml/hr and maintained for 5 hours. After 5 hours, infusion is titrated to a pH of \>7.30.
  • Balanced crystalloid solution — DRUG
    Intravenous infusion according to the treatment algorithm. Infusion starts with 100ml/hr until a pH of 7.30 - 7.35 and a Base Excess of ≥ 0 is reached. Then, infusion is reduced to 25ml/hr and maintained for 5 hours. After 5 hours, infusion is titrated to a pH of \>7.30.

Study Details

The study investigates whether sodium bicarbonate is able to reduce the occurrence of major adverse kidney events on day 90 (MAKE90) in critically ill patients with metabolic acidosis and acute kidney injury (AKI). While its efficacy in this context has been suggested in a subgroup analysis of the BICAR-ICU trial it has not been confirmed in a double-blinded randomized controlled trial to date.

Key Dates

First listed
Mar 11, 2026
Start date
May 31, 2026
Status verified
Apr 2026
Primary completion
Jun 30, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
660 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Sodium Bicarbonate
    Experimental: Sodium Bicarbonate 8.4% w/v Intravenous infusion according to the treatment algorithm targeting a pH\>7.30
  • Placebo Comparator: Balanced crystalloid solution
    Placebo: Balanced crystalloid solution Intravenous infusion according to the treatment algorithm targeting a pH\>7.30

Primary Outcome Measure

MAKE90 (consisting of mortality, dialysis within 90 days, persistent renal dysfunction (defined as serum creatinine ≥ 2x compared to baseline value at day 90) [ Time Frame: 90 days after randomization ]

Central Contacts

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