Completado

BICARICU-2Bicarbonato de Sodio Intravenoso para Acidosis Metabólica Severa y Lesión Renal Aguda de Moderada a Severa en Cuidados Críticos

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Objetivo del estudio

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.

Qué se está evaluando

Sodium bicarbonate infusion

Medicamento
Quiénes están siendo reclutados

Enfermedades Urogenitales+5

+ Desequilibrio Ácido-Base

+ Acidosis

A partir de 18 años
Ver todos los criterios de elegibilidad
Cómo está diseñado el estudio

Otro tipo de estudio

Intervencional
Inicio del estudio: octubre de 2019
Ver detalles del protocolo

Resumen

Patrocinador PrincipalUniversity Hospital, Montpellier
Última actualización: 28 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 7 de octubre de 2019

Fecha en la que se inscribió al primer participante.

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.

Título OficialSodium Bicarbonate for the Treatment of Severe Metabolic Acidosis With Moderate or Severe Acute Kidney Injury in the Critically Ill: a Randomized Clinical Trial
Patrocinador PrincipalUniversity Hospital, Montpellier
Última actualización: 28 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño

Se reclutarán 640 pacientes

Número total de participantes que el ensayo clínico espera reclutar.

Otro Tipo de Estudio

Algunos estudios exploran temas que no encajan en una categoría específica. Pueden incluir investigaciones innovadoras, nuevas tecnologías o áreas emergentes en el ámbito de la salud.



Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios

Cualquier sexo

Sexo biológico de los participantes elegibles para inscribirse.

A partir de 18 años

Rango de edades de los participantes que pueden unirse al estudio.

Voluntarios sanos no permitidos

Indica si personas sanas, sin la condición que se estudia, pueden participar.

Condiciones

Patología

Enfermedades UrogenitalesDesequilibrio Ácido-BaseAcidosisEnfermedades Urogenitales Femeninas y Complicaciones del EmbarazoEnfermedades RenalesEnfermedades metabólicasEnfermedades Nutricionales y MetabólicasEnfermedades Urológicas

Criterios

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 Estudio

Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.
Grupos de Tratamiento
Objetivos del Estudio

Un solo grupo de intervención está designado en este estudio

0% de probabilidad de ser asignado al grupo placebo

Grupos de Tratamiento

Grupo I

Experimental
Patients randomly assigned to bicarbonate group will receive intravenous 4.2% sodium bicarbonate titrated from 125ml to 250ml in 30min at physician's discretion to target a pH equal or above 7.30. Bicarbonate infusion will be repeated up to 1000ml per 24h. Arterial blood gases will be repeated from 3 to 6 times during the first 24h at physician's discretion

Objetivos del Estudio

Objetivos Primarios

Objetivos Secundarios

Centros del Estudio

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Este estudio tiene una ubicación

Suspendido

Service de médecine intensive et réanimation

Montpellier, FranceAbrir Service de médecine intensive et réanimation en Google Maps
Completado1 Centros de Estudio