Clinical trial • Not applicable • Endocrinology

SODIUM LACTATE for Diabetic ketoacidosis

Not applicable trial of SODIUM LACTATE for Diabetic ketoacidosis.

Overview

Trial Therapeutic Area
Endocrinology
Trial Disease
Diabetic ketoacidosis
Trial Stage
Not applicable
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
27-09-2024
First CTIS Authorization Date
10-01-2025

Trial design

Randomised, isotonic saline (sodium chloride infusion) versus ringer lactate (sodium lactate infusion); dose and schedule not specified in the available documentation.-controlled Not applicable trial across 16 sites in France.

Randomised
Yes
Comparator
Isotonic saline (SODIUM CHLORIDE infusion) versus Ringer lactate (SODIUM LACTATE infusion); dose and schedule not specified in the available documentation.
Target Sample Size
300
Trial Duration For Participant
1

Eligibility

Recruits 300 isVulnerablePopulationSelected: true. Informed consent obtained from adult participants using subject information and informed consent forms (documents: L1_SIS and ICF_adults). Specific forms are available for third parties/legal representatives (L1_SIS and ICF_Tiers), emergency situations (L2_Other subject information_Situation Urgence), and post-death/third-party post information (L1_SIS_TIERS-suite deces patient_FP, L1_SIS and ICF_TIERS-POST_FP). Minors are excluded (Patients <18 ans) so assent for children is not applicable..

Pregnancy Exclusion
Pregnant women
Vulnerable Population
isVulnerablePopulationSelected: true. Informed consent obtained from adult participants using subject information and informed consent forms (documents: L1_SIS and ICF_adults). Specific forms are available for third parties/legal representatives (L1_SIS and ICF_Tiers), emergency situations (L2_Other subject information_Situation Urgence), and post-death/third-party post information (L1_SIS_TIERS-suite deces patient_FP, L1_SIS and ICF_TIERS-POST_FP). Minors are excluded (Patients <18 ans) so assent for children is not applicable.

Inclusion criteria

  • {"criterion_text":"- Admission to emergency department or direct admission to ICU"}
  • {"criterion_text":"- Diagnosis of severe diabetic ketoacidosis requiring all the following criteria: o Blood or capillary glucose > 11 mmol/L o Ketonemia or ketonuria > 0 o Venous or arterial pH < 7.30 or venous or arterial bicarbonate < 15 mmol/L"}
  • {"criterion_text":"- Volume of fluid administered before inclusion <1L"}

Exclusion criteria

  • {"criterion_text":"- Patients <18 ans"}
  • {"criterion_text":"- Pregnant women"}
  • {"criterion_text":"- Contraindication to isotonic saline or Ringer Lactate"}
  • {"criterion_text":"- Patients with a decision to withdraw life-sustaining therapy"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Resolution of ketoacidosis allowing discharge from ICU, defined as the proportion of patients with the following three criteria at 24 hours from ICU admission : 1. capillary or blood glucose < 11 mmol/L 2. undetectable ketonemia or ketonuria 3. venous or arterial pH > 7.35 or venous or arterial bicarbonate > 20 mmol/L","definition_or_measurement_approach":"Proportion of patients meeting all three biochemical criteria measured at 24 hours from ICU admission (capillary/blood glucose, ketonemia/ketonuria, venous/arterial pH or bicarbonate)."}

Recruitment

Planned Sample Size
300
Recruitment Window Months
25
Consent Approach
Informed consent obtained from adult participants. Subject information and informed consent forms available for adults (L1_SIS and ICF_adults). Specific documents are provided for third-party/legal representatives (L1_SIS and ICF_Tiers), emergency inclusion situations (L2_Other subject information_Situation Urgence), and post-event/third-party post information (L1_SIS and ICF_Patient-Post, L1_SIS_TIERS-suite deces patient_FP, L1_SIS and ICF_TIERS-POST_FP). Documents appear to be in French (trial conducted in France). Minors are excluded from the trial.

Geography

Total Number Of Sites
16
Total Number Of Participants
300

France

Earliest CTIS Part Ii Submission Date
05-11-2024
Latest Decision Or Authorization Date
12-02-2026
Processing Time Days
464
Number Of Sites
16
Number Of Participants
300

Sites

Site Name
Assistance Publique Hopitaux De Paris
Department Name
Service Médecine Intensive Réanimation
Contact Person Name
HAFID AIT-OUFELLA
Contact Person Email
hafid.aitoufella@aphp.fr
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Service de Médecine Intensive Réanimation
Contact Person Name
Julien DEMISELLE
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Service de Médecine Intensive Réanimation
Contact Person Name
Jean REIGNIER
Contact Person Email
jean.reignier@chu-nantes.fr
Site Name
Centre Hospitalier D Avignon
Department Name
Service de Médecine Intensive Réanimation
Contact Person Name
Gael PRADEL
Contact Person Email
pradel.gael@ch-avignon.fr
Site Name
Centre Hospitalier Et Universitaire De Limoges
Department Name
Service des Urgences
Contact Person Name
Aloïse BLANCHET
Contact Person Email
Aloise.BLANCHET@chu-limoges.fr
Site Name
Centre Hospitalier D'Antibes Juan Les Pins
Department Name
Service de Médecine Intensive Réanimation
Contact Person Name
Cécilia BENARD
Contact Person Email
cecilia.benard@ch-antibes.fr
Site Name
Centre Jean Perrin
Department Name
Service de Médecine Intensive Réanimation
Contact Person Name
Bertrand SOUWEINE
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
Service de Médecine Intensive Réanimation
Contact Person Name
Boris JUNG
Contact Person Email
b-jung@chu-montpellier.fr
Site Name
Hospices Civils De Lyon
Department Name
Service de Médecine Intensive Réanimation
Contact Person Name
Louis CHAUVELOT
Contact Person Email
louis.chauvelot@chu-lyon.fr
Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Service de Médecine Intensive Réanimation
Contact Person Name
MATHIEU JOZWIAK
Contact Person Email
jozwiak.m@chu-nice.fr
Site Name
Centre Hospitalier Universitaire De Nimes
Department Name
Service Médecine Intensive Réanimation
Contact Person Name
CLAIRE ROGER
Contact Person Email
claire.roger@chu-nimes.fr
Site Name
Centre Hospitalier Intercommunal De Frejus-Saint-Raphaeel
Department Name
Service de Médecine Intensive Réanimation
Contact Person Name
Anthony VEYRON
Contact Person Email
anthony.veyron@chi-fsr.fr
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Service de Médecine Intensive Réanimation
Contact Person Name
Sébastien PREAU
Contact Person Email
sebastien.preau@chru-lille.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Service de Médecine Intensive Réanimation
Contact Person Name
Xavier MONNET
Contact Person Email
xavier.monnet@aphp.fr
Site Name
Centre Hospitalier Regional De Marseille
Department Name
Service de Médecine Intensive Réanimation
Contact Person Name
Sami HRAIECH
Contact Person Email
sami.hraiech@ap-hm.fr
Site Name
Centre Hospitalier De Cannes Simone Veil
Department Name
Service de Médecine Intensive Réanimation
Contact Person Name
Pierre-Marie BERTRAND
Contact Person Email
pm.bertrand@ch-cannes.fr

Sponsor

Primary sponsor

Full Name
Centre Hospitalier Universitaire De Nice
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
France

Investigational products

Investigational Product Name
SODIUM LACTATE
Active Substance
SODIUM LACTATE
Modality
Small molecule
Routes Of Administration
INFUSION
Route
INFUSION
Maximum Dose
7 l
Investigational Product Name
SODIUM CHLORIDE
Active Substance
SODIUM CHLORIDE
Modality
Small molecule
Routes Of Administration
INFUSION
Route
INFUSION
Maximum Dose
7 l

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