Targeted Therapeutic Mild Hypercapnia After Resuscitated Cardiac Arrest

NCT03114033 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1700

Last updated 2022-04-20

No results posted yet for this study

Summary

The TAME Cardiac Arrest trial will study the ability of higher arterial carbon dioxide (PaCO2) levels to reduce brain damage, comparing giving patients 'normal' to 'slightly higher than normal' blood PaCO2 levels and assessing their ability to return to normal life-tasks. It will be the largest trial ever conducted in heart attack patients in the intensive care unit. This therapy is cost free and, if shown to be effective, will improve thousands of lives, transform clinical practice, and yield major savings.

Conditions

  • Out-Of-Hospital Cardiac Arrest

Interventions

OTHER

Targeted therapeutic mild hypercapnia

Patients allocated to the TTMH protocol will be sedated to achieve moderate to deep sedation (a target Richmond Agitation Scale Score of -4). Arterial blood gases and end- tidal carbon dioxide levels will be measured at baseline and then used to guide respiratory rate adjustments of minute ventilation to remain within the target PaCO2 range of 50-55 mmHg. Arterial blood gases will be repeated every 4 hours for 24 hours following randomisation or if end-tidal carbon dioxide values change \>5 mmHg

OTHER

Targeted normocapnia (Standard care)

Patients allocated to the standard care (TN) protocol will be managed according to current practice and in accordance with ILCOR guidelines which recommend maintaining normocapnia in these patients. They will be sedated to achieve moderate to deep sedation (a target Richmond Agitation Scale Score of - 4). Arterial blood gases and end-tidal carbon dioxide levels will be measured at baseline and then used to guide respiratory rate adjustments of minute ventilation to remain within the target PaCO2 range of 35-45 mmHg. Arterial blood gases will be repeated every 4 hours for 24 hours following randomisation or if end-tidal carbon dioxide values change \>5 mmHg.

Sponsors & Collaborators

  • National Health and Medical Research Council, Australia

    collaborator OTHER
  • Health Research Board, Ireland

    collaborator OTHER
  • Australian and New Zealand Intensive Care Research Centre

    lead OTHER

Principal Investigators

  • Glenn M Eastwood, RN, PhD · Monash University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-15
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • Australia
  • Belgium
  • Denmark
  • Finland
  • France
  • Ireland
  • Italy
  • Netherlands
  • New Zealand
  • Norway
  • Saudi Arabia
  • Slovenia
  • Sweden
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03114033 on ClinicalTrials.gov