BICARICU-2Bicarbonate de sodium intraveineux pour l'acidose métabolique sévère et l'insuffisance rénale aiguë modérée à sévère en soins intensifs
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
Maladies génito-urinaires+9
+ Acidose
+ Déséquilibre Acido-Basique
Autre étude
Résumé
Date de début de l'étude : 7 octobre 2019
Date à laquelle le premier participant a commencé l'étude.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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.640 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Autre
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 18 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
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
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.Un seul groupe d'intervention est désigné dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
ExpérimentalObjectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site
Service de médecine intensive et réanimation
Montpellier, FranceOuvrir Service de médecine intensive et réanimation dans Google Maps