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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 146
- Locations
- 1
- Primary Endpoint
- To evaluate the effect of sodium bicarbonate therapy compared to placebo on
Study Overview
Brief Summary
Metabolic acidosis is defined as a decrease in blood pH below 7.35 due to reduced serum bicarbonate levels with a compensatory fall in arterial carbon dioxide. It is a common finding in critically ill patients with reported incidence ranging from 8 to 64 percent in intensive care units. Persistent acidemia is linked to poor prognosis with mortality rates reaching up to 57 percent when pH remains below 7.20. Management focuses on treating the underlying cause, optimizing tissue perfusion, and supportive strategies including mechanical ventilation and renal replacement therapy. Because acidemia can impair cellular function, intravenous sodium bicarbonate has been considered as a therapeutic option to raise pH and improve outcomes.
Survey data from North America show that more than two thirds of program directors in nephrology or intensive care report using sodium bicarbonate for acidemia with hyperlactatemia. The BICAR ICU trial demonstrated that sodium bicarbonate infusion improved survival and reduced mortality up to day 28 in patients with severe metabolic acidosis with pH at or below 7.20 and acute kidney injury. It also increased days alive without renal replacement therapy. However, no overall benefit was seen in the unselected population. These findings suggest a possible role of sodium bicarbonate in specific subgroups, and further studies are needed to clarify whether this treatment can improve survival in larger cohorts with severe metabolic acidosis.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
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.
- •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
- •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.
Outcomes
Primary Outcomes
To evaluate the effect of sodium bicarbonate therapy compared to placebo on
Time 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 at baseline, day 1, day 2, day3, day4, day5, day6, day7, day8, day9, day10, day11, day12, day13 and day 14.
the proportion of patients requiring renal replacement therapy in critically ill patients with severe metabolic acidosis and KDIGO stage 2–3 acute kidney injury.
Time 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 at baseline, day 1, day 2, day3, day4, day5, day6, day7, day8, day9, day10, day11, day12, day13 and day 14.
Secondary Outcomes
- 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.(sofa score at baseline, day 1, day2, day3, day4, & day 5)
Investigators
Aravind B Guledagudd
Bangalore Medical College and Research Institute