BICARICU-2Intravenous Sodium Bicarbonate for Severe Metabolic Acidosis and Moderate to Severe Acute Kidney Injury in Critical Care
This study aims to evaluate the effects of intravenous sodium bicarbonate on severe metabolic acidosis and moderate to severe acute kidney injury in critical care patients, with the primary focus on the all-cause mortality rate after 90 days.
Sodium bicarbonate infusion
Urogenital Diseases+9
+ Acid-Base Imbalance
+ Acidosis
Other Study
Summary
Study start date: October 7, 2019
Actual date on which the first participant was enrolled.This study focuses on critically ill patients with severe metabolic acidosis, a condition where the body produces too much acid, and moderate or severe acute kidney injury. The main goal is to evaluate if sodium bicarbonate, a widely available medication, can improve outcomes in these patients. Severe metabolic acidosis can lead to poor health outcomes, with a mortality rate as high as 57% when the body's pH stays below 7.20 for more than 24 hours. Acute kidney injury is commonly associated with this condition, occurring in 35-40% of critically ill patients. Despite current treatments, the mortality rate for moderate to severe acute kidney injury with severe acidosis remains high, at over 50%. This study aims to address this unmet need by investigating the potential benefits of sodium bicarbonate. In this study, participants with severe metabolic acidosis and moderate or severe acute kidney injury will receive an infusion of sodium bicarbonate. The primary outcome being evaluated is whether sodium bicarbonate infusion improves the composite criteria of organ failure at day 7 and any cause of death at day 28, compared to no bicarbonate infusion. The infusion will be administered using a 4.2% sodium bicarbonate solution, with doses ranging from 125ml to 250ml given over 30 to 240 minutes. The study is innovative as it is the first randomized clinical trial to investigate the association between sodium bicarbonate infusion and day 90 mortality in critically ill patients with both severe acidosis and moderate to severe acute kidney injury.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.640 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Other Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Aged from 18 years old * Admitted in the ICU where the BICARICU-2 trial takes place * Within 6h before enrolment, the patient MUST present on the same arterial blood gas (the last available before enrollment) the 3 following criteria: pH ≤ 7.20 ; Bicarbonatemia ≤ 20 mmol/l ; AND PaCO2 ≤ 45mmHg ; * Moderate to severe acute kidney injury ("Kidney Disease Improving Global Outcome", KDIGO group of 2 or 3) * Within 48h of ICU admission, a total SOFA ≥ 4 OR an arterial lactate concentration ≥ 2 mmol/l * Signed informed consent form. According to the French law, considering the severity of the illness, the fact that most of these patients would be unable to consent (sedation or potential delirium) and that their proxies might not be contactable at the time of inclusion, a deferred consent process for emergency situations will be enabled. When deferred consent will be used, written permission to pursue the research will be obtained from the patient or proxy as soon as possible. If this consent is not obtained, the patient's data will not be used and they will be withdrawn from the trial. * Subjects must be covered by public health insurance Exclusion Criteria: * Pure respiratory acidosis (defined by pH 7.20, PaCO2 \>50 mmHg, bicarbonatemia equal or greater than (PaCO2-40)/10 + 24), digestive or urinary tract proven loss of fluid (equal or greater than 1500ml/24h) with concomitant loss of sodium bicarbonate, chronic kidney insufficiency (creatinine clearance ≤ 10ml/min), proven tubular acidosis, ketoacidosis, exogenous acids poisoning (aspirin, methanol, ), PaCO2 \> 45 mmHg and spontaneous breathing, sodium bicarbonate infusion or renal replacement therapy within 24h prior to screening prior to screening or imminent in the next 6h. * Pregnant or breast feeding patient * Patient who is in a dependency or employment with the sponsor or the investigator * Patient who was enrolled in another study and who is in the exclusion period for any enrolment in the present study * Life expectancy less than 48h * Consent refusal from the patient or his/her next of kin and the impossibility to enrol using the emergency procedure * Patients protected by law (Art.L 1121-5, 1121-6, 1121-8 du Code de la santé publique) * Absence of a French Health Care Insurance coverage
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Service de médecine intensive et réanimation
Montpellier, FranceOpen Service de médecine intensive et réanimation in Google Maps