Clinical trial • Phase IV • Neurology | Cardiology
Sodium lactate for Post-anoxic brain injury | Post-cardiac arrest syndrome | Coma | Cardiac arrest
Phase IV trial of Sodium lactate for Post-anoxic brain injury | Post-cardiac arrest syndrome | Coma | Cardiac arrest.
Overview
- Trial Therapeutic Area
- Neurology | Cardiology
- Trial Disease
- Post-anoxic brain injury | Post-cardiac arrest syndrome | Coma | Cardiac arrest
- Trial Stage
- Phase IV
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 27-06-2024
- First CTIS Authorization Date
- 12-09-2024
Trial design
Randomised, open-label, standard of care group: a balanced crystalloid solution (plasmalyte a viaflo, baxter) administered intravenously at the corresponding equivalent volume. (no dose schedule specified for comparator in the record.)-controlled Phase IV trial across 4 sites in Belgium.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Standard of care group: A balanced crystalloid solution (Plasmalyte A Viaflo, Baxter) administered intravenously at the corresponding equivalent volume. (No dose schedule specified for comparator in the record.)
- Target Sample Size
- 125
- Trial Duration For Participant
- 90
Eligibility
Recruits 125 Vulnerable population selected: comatose patients (isVulnerablePopulationSelected = true). Subject information and informed consent forms and an 'informed_consent_procedure' document are listed in the application, but specific details on surrogate consent or assent procedures are not provided in the available record..
- Pregnancy Exclusion
- Pregnant women
- Vulnerable Population
- Vulnerable population selected: comatose patients (isVulnerablePopulationSelected = true). Subject information and informed consent forms and an 'informed_consent_procedure' document are listed in the application, but specific details on surrogate consent or assent procedures are not provided in the available record.
Inclusion criteria
- {"criterion_text":"- Age > 18 years old\n- Sustained return of spontaneous circulation (ROSC) ≥ 20 minutes\n- Comatose state (Glasgow coma scale - GCS < 9)\n- Time to ROSC > 15'"}
Exclusion criteria
- {"criterion_text":"- Pregnant women\n- Anticipated withdrawal of support within 24 hours\n- Traumatic cause of cardiac arrest\n- Body weight at admission > 120 Kg"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Neuron specific enolase (NSE) plasmatic peak values at 48 hours after return of spontaneous circulation.","definition_or_measurement_approach":"Plasmatic peak values of NSE measured at 48 hours after return of spontaneous circulation."}
Secondary endpoints
- {"endpoint_text":"- Modified Rankin Scale at 90 days","definition_or_measurement_approach":"Functional outcome measured using the Modified Rankin Scale at 90 days."}
- {"endpoint_text":"- ICU length of stay (days), Hospital length of stay (days).","definition_or_measurement_approach":"Duration of ICU and hospital stay measured in days."}
- {"endpoint_text":"- Mortality during ICU stay, during hospital stay, at 90 days.","definition_or_measurement_approach":"All-cause mortality assessed during ICU stay, hospital stay and at 90 days."}
- {"endpoint_text":"- Vasopressor equivalent dose during the first 48h after resuscitation.","definition_or_measurement_approach":"Vasopressor dose expressed as vasopressor equivalent during first 48 hours post-resuscitation."}
- {"endpoint_text":"- Seizures episodes during the first 24h, 48h and ICU stay.","definition_or_measurement_approach":"Incidence of seizure episodes recorded during first 24h, 48h and throughout ICU stay."}
- {"endpoint_text":"- Peak plasmatic concentrations or neurofilament light chain (NFL) at 24, 48 and 72h.","definition_or_measurement_approach":"Plasmatic peak concentrations of NFL measured at 24, 48 and 72 hours."}
- {"endpoint_text":"- Peak plasmatic concentrations or glial fibrillary acid protein (GFAP) at 24, 48 and 72h","definition_or_measurement_approach":"Plasmatic peak concentrations of GFAP measured at 24, 48 and 72 hours."}
- {"endpoint_text":"- Peak plasmatic concentrations or Troponin I (TnI) at 24, 48 and 72h","definition_or_measurement_approach":"Plasmatic peak concentrations of Troponin I measured at 24, 48 and 72 hours."}
- {"endpoint_text":"- Incidence, nature, and severity of adverse events graded according to National Cancer Institute - Common Terminology Criteria for Adverse Events.","definition_or_measurement_approach":"Adverse events captured and graded according to NCI-CTCAE; incidence, nature and severity documented."}
Recruitment
- Planned Sample Size
- 125
- Recruitment Window Months
- 74
- Consent Approach
- Subject information and informed consent forms are provided (documents: L1_SIS_ICF_BE_EN_Redacted, L1_SIS_ICF_BE_FR_Redacted, L1_SIS_ICF_BE_NL_Redacted) and an 'L1_informed_consent_procedure' document is listed. Consent form languages available: English, French, Dutch. Specifics on who provides consent for comatose participants (e.g., legal representative/surrogate) are not detailed in the available record.
Geography
- Total Number Of Sites
- 4
- Total Number Of Participants
- 125
Belgium
- Earliest CTIS Part Ii Submission Date
- 26-08-2024
- Latest Decision Or Authorization Date
- 23-02-2026
- Processing Time Days
- 546
- Number Of Sites
- 4
- Number Of Participants
- 125
Sites
- Site Name
- CHC MontLegia
- Department Name
- Intensive care
- Contact Person Name
- Pierre Demaret
- Contact Person Email
- pierre.demaret@chc.be
- Site Name
- Hopital Erasme
- Department Name
- Intensive Care
- Contact Person Name
- Fabio Taccone
- Contact Person Email
- fabio.taccone@hubruxelles.be
- Site Name
- Clinique Saint-Pierre
- Department Name
- Intensive care
- Contact Person Name
- Nicolas Serck
- Contact Person Email
- nicolas.serck@cspo.be
- Site Name
- CHU Saint Pierre
- Department Name
- Emergency Department
- Contact Person Name
- Stefano Malinverni
- Contact Person Email
- stefano.malinverni@stpierre-bru.be
Sponsor
Primary sponsor
- Full Name
- Hopital Erasme
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Belgium
Investigational products
- Investigational Product Name
- SODIO LATTATO MONICO 2 mEq/ml concentrato per soluzione per infusione
- Active Substance
- Sodium lactate
- Modality
- Small molecule
- Routes Of Administration
- Intravenous infusion
- Route
- Intravenous infusion
- Authorisation Status
- Marketing authorisation in IT (marketingAuthNumber: 030823126)
- Maximum Dose
- 22 mmol/kg
- Investigational Product Name
- Plasmalyte A Viaflo, solution pour perfusion
- Active Substance
- magnesium chloride hexahydrate, potassium chloride, sodium chloride, sodium acetate trihydrate, sodium gluconate
- Modality
- Small molecule
- Routes Of Administration
- Intravenous infusion
- Route
- Intravenous infusion
- Authorisation Status
- Marketing authorisation (mrp IE/H/0803/001; marketingAuthNumber: 0952636)
- Maximum Dose
- 510 ml
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