IL Ancillary Study of the Therapeutic Hypothermia After Nonshockable Cardiac Arrest Trial.

NCT02711098 | Completed Phase 3 DMC

• 1 other identifier: IL Ancillary Study of HYPERION
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 14

Brief Summary

Cardiac arrest is at present a major cause of mortality as well as a cause of disability for the surviving victims.In Europe, every year counts as 300,000 cardiac arrests responsible for 250,000 deaths. Thus, less than 20 % of patients discharged home with impaired quality of life associated with symptoms of tiredness, stress, anxiety. The prognosis is related to the initial cardiac rhythm present during the initiation of resuscitation. Recent progress in the improvement of mortality and neurological outcome has been achieved over the last decade thanks to the systematic implementation of a period of targeted temperature control between 32 and 34 ° C in patients who benefited from the realization of at least one electrical external shock. There are theoretical and clinical arguments to think that achieving the same way a period of targeted temperature control between 32 and 34 ° C in patients treated for cardiac arrest with a non- shockable rhythm on arrival can also benefit from this procedure. However other arguments are against this hypothesis including an increase in the risk of infection , worsening of the patient's hemodynamic status with no benefit to him. To answer this question, we conduce a randomized multicenter study testing the potential improvement of neurological outcome through this procedure targeted temperature control between 32.5 and 33.5 ° C in these patients. IL Ancillary Study of HYPERION Trial will determine impact on inflammatory biomarkers of two temperature target for targeted temperature management (33°C or 37°C) after cardiac arrest in non-shockable rhythm.

Conditions

Cardiac Arrest

Keywords

cardiac arrest; hypothermia; critical care

Outcome Measures

Primary Outcomes (1)

• Interleukine 6 level between H0 and H72

  Comparing the production of interleukin 6 (inflammatory cytokine) during targeted temperature management at 33 or 37 °C after cardiac arrest in non-shockable rhythm when help arrived and before the injection of adrenaline. The analysis of the primary endpoint will be performed using an analysis of covariance, taking into account the basal value of interleukine 6. Necessary data will be pre-processed.

  72 hours

Study Arms (2)

Targeted controlled temperature between 32.5 and 33.5°C

ACTIVE COMPARATOR

Patients will be placed in targeted temperature control between 32.5 and 33.5 ° C for 24 hours and then slowly rewarmed for targeted temperature control between 36.5 and 37.5 ° C for 24 hours.

Biological: Inflammatory biomarkers dosage "Hypothermia Arm"

Targeted controlled temperature between 36.5 and 37.5°C

PLACEBO COMPARATOR

Patients will be placed in targeted temperature control between 36.5 and 37.5 ° C for 48 hours.

Biological: Inflammatory biomarkers dosage "Normothermia Arm"

Interventions

Inflammatory biomarkers dosage "Hypothermia Arm" BIOLOGICAL

There is 6 dosage of inflammatory biomarker per patient included: H0, H12, H24, H36, H48 and H72 during targeted temperature management between 33°C and 37°C.

Targeted controlled temperature between 32.5 and 33.5°C

Inflammatory biomarkers dosage "Normothermia Arm" BIOLOGICAL

There is 6 dosage of inflammatory biomarker per patient included: H0, H12, H24, H36, H48 and H72 during targeted temperature management at 37°C.

Targeted controlled temperature between 36.5 and 37.5°C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cardiac arrest in nonshockable rhythm and
• Glasgow Coma Scale score ≤8. In patients receiving sedative therapy at ICU admission, the Glasgow Coma Scale score assessed by the emergency physician just before sedative therapy initiation is used.
• Patient must be randomized in a center which participate in the ancillary study.

You may not qualify if:

• No-flow time \>10 min (time from collapse to initiation of external cardiac massage);
• Low-flow time \>60 min (time from initiation of external cardiac massage to return of spontaneous circulation).
• Major hemodynamic instability (defined as a continuous epinephrine or norepinephrine infusion at a flow rate \>1 μg/Kg/min)
• Moribund patient
• Child C cirrhosis of the liver
• Age \<18 years
• Pregnant or breastfeeding woman
• Correctional facility inmate
• Patient without health insurance
• Decision by the patient or next of kin to refuse the study

Sponsors & Collaborators

• Centre Hospitalier Departemental Vendee: lead

Study Sites (14)

Centre hospitalier d'Annecy

Annecy, 74374, France

Location

Medical Intensive Care Unit

Clermond Ferrand, France

Location

CHU Dijon

Dijon, 21079, France

Location

Medical Surgical Intensive Care Unit

La Roche-sur-Yon, France

Location

Medical Surgical Intensive Care Unit

Lens, France

Location

Medical Surgical Intensive Care Unit

Limoges, France

Location

Medical Surgical Intensive Care Unit

Montauban, France

Location

Medical Intensive Care Unit

Nantes, France

Location

CHU Orleans

Orléans, France

Location

Medical Intensive Care Unit

Poitiers, France

Location

Medical Surgical Intensive Care Unit

Rodez, France

Location

Medical Surgical Intensive Care Unit

Saint-Brieuc, France

Location

Medical Surgical Intensive Care Unit

St-Malo, France

Location

CHU Tours

Tours, France

Location

Related Links

• Related Info

MeSH Terms

Conditions

Heart Arrest; Hypothermia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jean-Baptiste Lascarrou, MD

  CHD Vendee

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2016
• First Posted: March 17, 2016
• Study Start: March 1, 2016
• Primary Completion: January 14, 2018
• Study Completion: January 14, 2018
• Last Updated: February 25, 2019

Record last verified: 2019-01

Locations

FR (14)