Administrative information
Title {1} | Interleukin-6 Receptor Antibodies for Modulating the Systemic Inflammatory Response after Out-of-Hospital Cardiac Arrest (IMICA): study protocol for a double-blinded, placebo-controlled, single-center, randomized clinical trial |
Trial registration {2a and 2b}. | ClinicalTrials.gov Identifier: NCT03863015 EudraCT: 2018-002686-19 |
Protocol version {3} | Version: 1.91 of November 1, 2019 (Minor updates to v. 1.9 of October 25, 2018) |
Funding {4} | Hjertecenterets Forskningsudvalg (The Heart Center Research Council, Rigshospitalet): The cost of establishing the biobank. Hjerteforeningen (Danish Heart Foundation): Funding of salary for MASM in 1 year and funding of analysis of biomarkers from the biobank, the cost of personnel involved in the MR substudy, as well as covering costs for presentations of the study results at conferences. Region Hovedstadens Forskningsfond til sundhedsforskning, Denmark (Captial Region Research foundation): Salary for MASM NovoNordisk Foundation: JK is supported by an unrestricted grant from the NovoNordisk Foundation (grant NNF17OC0028706) for research in post-cardiac arrest management. |
Author details {5a} | All authors: Dept. of Cardiology, The Heart Centre, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark |
Name and contact information for the trial sponsor {5b} | Trial sponsor-investigator: Christian Hassager, Professor, MD, DMSc Dept. of Cardiology, The Heart Centre, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark Email: Christian.hassager@regionh.dk |
Role of sponsor {5c} | This is a sponsor-investigator-initiated study with no funding or involvement from pharmaceutical companies, and the sponsor-investigator maintains authority over all aspects of the trial including, design, management, interpretation of results, and publication. |
Introduction
Background and rationale {6a}
Objectives {7}
Primary objective
Secondary objective
Hypothesis
Trial design {8}
Methods: participants, interventions, and outcomes
Study setting {9}
Eligibility criteria {10}
Inclusion criteria
Exclusion criteria
Who will take informed consent? {26a}
Additional consent provisions for collection and use of participant data and biological specimens {26b}
Interventions
Explanation for the choice of comparators {6b}
Intervention description {11a}
Criteria for discontinuing or modifying allocated interventions {11b}
Strategies to improve adherence to interventions {11c}
Relevant concomitant care permitted or prohibited during the trial {11d}
Provisions for post-trial care {30}
Outcomes {12}
Primary endpoint
Secondary endpoints
Clinical endpoints
Safety
Participant timeline {13}
Study period | ||||||||
---|---|---|---|---|---|---|---|---|
Enrollment | Post-allocation | Follow-up | ||||||
Timepoint | 0 h | 6 h | 12 h | 24 h | 36 h | 48 h | 72 h | Days 30, 90, and 180 |
Enrollment | ||||||||
Eligibility screen | x | |||||||
Informed consent | Legal guardian and next of kin | Patient as soon as possible | ||||||
Randomization | x | |||||||
Interventions | ||||||||
Preparation of study drug and beginning of 1-h infusion | x | |||||||
Assessments | ||||||||
Biochemestry1 | x | x | x | x | x | x | x | |
Biobank samples | x | x | x | x | ||||
ECG | x | x | x | x | x | x | x | |
Swan-Ganz based measurements | x | x | x | x | x | x | x | |
Echocardiography | Day 1 | Either day 3, 4, or 5 | ||||||
ABG and VBG2 | x | x | x | x | x | x | x | |
SOFA score | x | x | x | |||||
CPC and mRS score | x | |||||||
MOCA score | Only day 90 |