Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
125
Countries
1
Sites
4
post-anoxic brain injury
To evaluate the efficacy of hypertonic sodium lactate infusion to decrease brain injury after cardiac arrest in comatose survivors.
Key facts
- Sponsor
- Hopital Erasme
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10], Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 18 Feb 2025 → ongoing
- Decision date (initial)
- 2024-09-12
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Fonds Erasme pour la Recherche Medicale · ESICM (European Society of Intensive Care)
External identifiers
- EU CT number
- 2023-506031-15-01
- ClinicalTrials.gov
- NCT05004610
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Safety, Efficacy
To evaluate the efficacy of hypertonic sodium lactate infusion to decrease brain injury after cardiac arrest in comatose survivors.
Secondary objectives 9
- To further evaluate the efficacy of the treatment on neurological outcome.
- To further evaluate the efficacy of the treatment on the hospitalization time.
- To further evaluate the efficacy of the treatment on the mortality.
- To further evaluate the efficacy of the treatment on the need for vasopressors.
- To further evaluate the efficacy of the treatment on the incidence of epilepsy.
- To further evaluate the efficacy of the treatment on neuronal damage.
- To further evaluate the efficacy of the treatment on astroglial damage.
- To further evaluate the efficacy of the treatment on myocardial damage.
- To evaluate the safety of the hypertonic sodium lactate treatment.
Conditions and MedDRA coding
post-anoxic brain injury
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10078202 | Post cardiac arrest syndrome | 100000004852 |
| 20.0 | PT | 10007515 | Cardiac arrest | 100000004849 |
| 21.1 | LLT | 10002663 | Anoxic brain damage | 10029205 |
| 20.0 | PT | 10010071 | Coma | 100000004852 |
| 21.1 | PT | 10063837 | Reperfusion injury | 100000004866 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | main trial Eligible patients will be then randomized to receive either hypertonic sodium lactate (treated
group) or an equivalent volume of Plasmalyte A Viaflo (standard of care group)
|
Randomised Controlled | None | Treated group: hypertonic sodium lactate as concentrated solution 2 mEq/ml will be diluted in sterile water for intravenous injections to produce a 1M hypertonic sodium lactate solution. Standard of care group: A balanced crystalloid solution (Plasmalyte A Viaflo, Baxter) will be intravenously administrated at the corresponding equivalent volume. |
Regulatory references
- Plan to share IPD
- Yes
| EU CT number | Title | Sponsor |
|---|---|---|
| 2023-506031-15-00 | Hypertonic LActaTe afTer cardiac arrEst: the LATTE trial | Hopital Erasme |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Age > 18 years old
- Sustained return of spontaneous circulation (ROSC) ≥ 20 minutes
- Comatose state (Glasgow coma scale - GCS < 9)
- Time to ROSC > 15'
Exclusion criteria 4
- Pregnant women
- Anticipated withdrawal of support within 24 hours
- Traumatic cause of cardiac arrest
- Body weight at admission > 120 Kg
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Neuron specific enolase (NSE) plasmatic peak values at 48 hours after return of spontaneous circulation.
Secondary endpoints 9
- Modified Rankin Scale at 90 days
- ICU length of stay (days), Hospital length of stay (days).
- Mortality during ICU stay, during hospital stay, at 90 days.
- Vasopressor equivalent dose during the first 48h after resuscitation.
- Seizures episodes during the first 24h, 48h and ICU stay.
- Peak plasmatic concentrations or neurofilament light chain (NFL) at 24, 48 and 72h.
- Peak plasmatic concentrations or glial fibrillary acid protein (GFAP) at 24, 48 and 72h
- Peak plasmatic concentrations or Troponin I (TnI) at 24, 48 and 72h
- Incidence, nature, and severity of adverse events graded according to National Cancer Institute - Common Terminology Criteria for Adverse Events.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SODIO LATTATO MONICO 2 mEq/ml concentrato per soluzione per infusione
PRD804364 · Product
- Active substance
- Sodium Lactate
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 22 mmol/kg millimole(s)/kilogram
- Max total dose
- 22 mmol/kg millimole(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- B05XA — ELECTROLYTE SOLUTIONS
- Marketing authorisation
- 030823126
- MA holder
- MONICO S.P.A.
- MA country
- Italy
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
Plasmalyte A Viaflo, solution pour perfusion
PRD11026245 · Product
- Active substance
- Magnesium Chloride Hexahydrate
- Substance synonyms
- MAGNESIUM CHLORIDE HEXAHYDRATE (E511)
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 510 ml millilitre(s)
- Max total dose
- 510 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- B05BB01 — ELECTROLYTES
- Marketing authorisation
- 0952636
- MA holder
- BAXTER SA
- MA country
- Luxembourg
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Hopital Erasme
- Sponsor organisation
- Hopital Erasme
- Address
- Lennikse Baan 808
- City
- Anderlecht
- Postcode
- 1070
- Country
- Belgium
Scientific contact point
- Organisation
- Hopital Erasme
- Contact name
- Biomedical research service
Public contact point
- Organisation
- Hopital Erasme
- Contact name
- Biomedical research service
Locations
1 EU/EEA country · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 125 | 4 |
| Rest of world | — | 0 | — |
Investigational sites
Clinique Saint-Pierre
Intensive care, Avenue Reine Fabiola 9, 1340, Ottignies-Louvain-La-Neuve
CHU Saint Pierre
Emergency Department, Hoogstraat 322, 1000, Brussels
CHC MontLegia
Intensive care, Boulev. De Patience Et Beajonc 2, 4000, Liege
Hopital Erasme
Intensive Care, Lennikse Baan 808, 1070, Anderlecht
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 |
|---|---|---|---|---|---|
| Belgium | 2025-02-18 | 2025-03-21 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 12 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2023-506031-15-01_Redacted | 2.0 |
| Protocol (for publication) | D1_Protocol_2023-506031-15-01_TC_Redacted | 1.1 |
| Recruitment arrangements (for publication) | K1_Recruitment-Arrangements | 1.0 |
| Subject information and informed consent form (for publication) | L1_informed_consent_procedure | 1 |
| Subject information and informed consent form (for publication) | L1_SIS_ICF_BE_EN_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS_ICF_BE_FR_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS_ICF_BE_NL_Redacted | 2.0 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Sodium_Lactate | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol_synopsis_BE_2023-506031-15-01_DE | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol_synopsis_BE_2023-506031-15-01_EN | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol_synopsis_BE_2023-506031-15-01_FR | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol_synopsis_BE_2023-506031-15-01_NL | 2.0 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-27 | Belgium | Acceptable 2024-09-11
|
2024-09-12 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-09-17 | Belgium | Acceptable | 2024-10-18 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-12-11 | Belgium | Acceptable 2026-02-23
|
2026-02-23 |