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Study to know whether giving sodium bicarbonate, a medicine that reduces blood acidity, can lower the need for dialysis in critically ill patients with severe acidosis and kidney failure

A randomized controlled trial to evaluate the effect of sodium bicarbonate versus placebo on renal replacement therapy requirement in critically ill patients with severe metabolic acidosis and acute kidney injury - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/10/095613
Enrollment
146
Registered
2025-10-06
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-13

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

Conditions

Health Condition 1: N179- Acute kidney failure, unspecified

Interventions

Intervention1: sodium bicarbonate group: Patients in the sodium bicarbonate group will receive an intravenous 3.75 percent sodium bicarbonate solution, given in 125 to 250 mL over 30 minutes at the ph

Sponsors

Department of Critical Care Medicine
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Within 6 hours before enrolment, the patient must present on the same arterial blood gas (the last available before enrolment) the three following criteria pH less than or equal to7.20. Bicarbonate less than or equal to20mmol/L PaCO2 less than or equal to 45mm Hg. Moderate-to-severe acute kidney injury (Kidney Disease Improving Global Outcome, group of 2 or 3). Within 24 hours of ICU admission, a total SOFA more than or equal to 4 or an arterial lactate concentration more than or equal to 2mmol per L. Signed informed consent form.

Exclusion criteria

Exclusion criteria: Pure respiratory acidosis (defined by pH less than or equal to 7.20, PaCO2 more than or equal to50mm Hg, bicarbonate equal or greater than (PaCO2 minus 40) divided by 10 plus 24). Digestive or urinary tract proven loss of fluid (equal or greater than 1500mL per 24hours) with concomitant loss of sodium bicarbonate, Stage IV or V chronic kidney disease, Proven tubular acidosis. Ketoacidosis. Exogenous acids poisoning (aspirin, methanol), Sodium bicarbonate infusion or renal replacement therapy within 24hours prior to screening or imminent in the next 6hours. Hyperkalemia more than 6.5 with ECG changes. Pregnant or breastfeeding patient. Patient who was enrolled in another study and who is in the exclusion period for any enrolment in the present trial. Life expectancy less than 24hours.

Design outcomes

Primary

MeasureTime frame
To evaluate the effect of sodium bicarbonate therapy compared to placebo on the proportion of patients requiring renal replacement therapy in critically ill patients with severe metabolic acidosis and KDIGO stage 2 3 acute kidney injury. Timepoint: To evaluate the effect of sodium bicarbonate therapy compared to placebo on the proportion of patients requiring renal replacement therapy in critically ill patients with severe metabolic acidosis and KDIGO stage 2 3 acute kidney injury at baseline, day 1, day 2, day3, day4, day5, day6, day7, day8, day9, day10, day11, day12, day13 and day 14.—

Secondary

MeasureTime frame
To assess the effect of sodium bicarbonate versus placebo on SOFA score over 5 days & fluid balance on Day 2 in critically ill patients with severe metabolic acidosis & KDIGO stage 2 3 AKI.Timepoint: sofa score at baseline, day 1, day2, day3, day4, & day 5 fluid balance at day 1 & day 2—

Countries

India

Contacts

Public ContactDr Vijayakumar H N

Bangalore Medical College and Research Institute

viji2751977@gmail.com9886504680

Outcome results

None listed

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