Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
300
Countries
1
Sites
16
Diabetic keto-acidosis
To compare fluid resuscitaiton with Ringer Lactate to isotonic saline on the resolution of diabetic ketoacidosis at 24 hours from admission to Intensive Care Unit (ICU) in patients with severe diabetic ketoacidosis.
Key facts
- Sponsor
- Centre Hospitalier Universitaire De Nice
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Trial duration
- 23 Oct 2025 → ongoing
- Decision date (initial)
- 2025-01-10
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Therapy
To compare fluid resuscitaiton with Ringer Lactate to isotonic saline on the resolution of diabetic ketoacidosis at 24 hours from admission to Intensive Care Unit (ICU) in patients with severe diabetic ketoacidosis.
Conditions and MedDRA coding
Diabetic keto-acidosis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | PT | 10012671 | Diabetic ketoacidosis | 100000004861 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Admission to emergency department or direct admission to ICU
- 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
- Volume of fluid administered before inclusion <1L
Exclusion criteria 4
- Patients <18 ans
- Pregnant women
- Contraindication to isotonic saline or Ringer Lactate
- Patients with a decision to withdraw life-sustaining therapy
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 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
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
SUB12581MIG · Substance
- Active substance
- Sodium Chloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INFUSION
- Max daily dose
- 7 l litre(s)
- Max total dose
- 7 l litre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB15300MIG · Substance
- Active substance
- Sodium Lactate
- Pharmaceutical form
- INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 7 l litre(s)
- Max total dose
- 7 l litre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Universitaire De Nice
- Sponsor organisation
- Centre Hospitalier Universitaire De Nice
- Address
- 4 Avenue Reine Victoria
- City
- Nice
- Postcode
- 06000
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Universitaire De Nice
- Contact name
- Pr Mathieu JOZWIAK
Public contact point
- Organisation
- Centre Hospitalier Universitaire De Nice
- Contact name
- Dominique DONZEAU
Locations
1 EU/EEA country · 16 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 300 | 16 |
| Rest of world | — | 0 | — |
Investigational sites
Assistance Publique Hopitaux De Paris
Service Médecine Intensive Réanimation, 184 Rue Du Faubourg Saint Antoine, 75012, Paris
Centre Hospitalier Universitaire De Nimes
Service Médecine Intensive Réanimation, Place Du Professeur Robert Debre, 30900, Nimes
Centre Hospitalier Intercommunal De Frejus-Saint-Raphaeel
Service de Médecine Intensive Réanimation, 240 Avenue De Saint Lambert, 83600, Frejus
Centre Hospitalier Universitaire De Nantes
Service de Médecine Intensive Réanimation, 30 Boulevard Jean Monnet, 44000, Nantes
Centre Hospitalier Et Universitaire De Limoges
Service des Urgences, 2 Avenue Martin Luther King, 87000, Limoges
Centre Hospitalier Universitaire De Montpellier
Service de Médecine Intensive Réanimation, 191 Avenue Du Doyen Gaston Giraud, 34295, Montpellier Cedex 5
Centre Hospitalier Universitaire De Nice
Service de Médecine Intensive Réanimation, 151 Route De Saint Antoine, 06200, Nice
Centre Hospitalier De Cannes Simone Veil
Service de Médecine Intensive Réanimation, 15 Avenue Des Broussailles, Cs 50008, Cannes Cedex
Centre Hospitalier D Avignon
Service de Médecine Intensive Réanimation, 305 Rue Raoul Follereau, 84000, Avignon
Centre Jean Perrin
Service de Médecine Intensive Réanimation, 58 Rue Montalembert, 63000, Clermont-Ferrand
Centre Hospitalier Universitaire De Lille
Service de Médecine Intensive Réanimation, Rue Emile Laine, 59037, Lille Cedex
Les Hopitaux Universitaires De Strasbourg
Service de Médecine Intensive Réanimation, 1 Place De L Hopital, Cs 80426, Strasbourg Cedex
Assistance Publique Hopitaux De Paris
Service de Médecine Intensive Réanimation, 78 Rue Du General Leclerc, 94270, Le Kremlin-Bicetre
Hospices Civils De Lyon
Service de Médecine Intensive Réanimation, 103 Grande Rue De La Croix Rousse, 69317, Lyon Cedex 04
Centre Hospitalier D'Antibes Juan Les Pins
Service de Médecine Intensive Réanimation, 107 Avenue De Nice, 06606, Antibes Cedex
Centre Hospitalier Regional De Marseille
Service de Médecine Intensive Réanimation, 265 Chemin Des Bourrely, 13015, Marseille
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2025-10-23 | 2025-11-26 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 15 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol Annexe 1_FR_2024-511513-37-00 | 0.0 |
| Protocol (for publication) | D1_Protocol Annexe 2_FR_2024-511513-37-00 | 0.0 |
| Protocol (for publication) | D1_Protocol_2024-511513-37-00_FP | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangement | 1.0 |
| Recruitment arrangements (for publication) | P2_Additionnel_2024-511513-37-00_FP | 0.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_adults | 0.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Patient-Post | 0.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Tiers | 0.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_TIERS-POST_FP | 0.0 |
| Subject information and informed consent form (for publication) | L1_SIS_TIERS-suite deces patient_FP | 0.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information_Situation Urgence | 0.0 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Chlorure de Sodium | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Ringer Lactate | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_FR_2024-511513-37-00 | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_FR_2024-511513-37-00_TC | 1.0 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-27 | France | Acceptable 2025-01-10
|
2025-01-10 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-12-16 | France | Acceptable 2026-02-11
|
2026-02-12 |