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Clinical Trials/NCT04650412
NCT04650412
Terminated
N/A

Integrated Care of Co-morbidities vs Standard Care After Acute Hypercapnic Respiratory Failure in the Intensive Care Unit: a Randomized Controlled Trial

CTU3 sites in 2 countries188 target enrollmentMay 28, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Acute Hypercapnic Respiratory Failure
Sponsor
CTU
Enrollment
188
Locations
3
Primary Endpoint
Hospital readmission
Status
Terminated
Last Updated
2 years ago

Overview

Brief Summary

The study will assess the potential benefit of implementing a complex bundle of interventions to treat important - often unrecognized - comorbidities in patients surviving an episode of Acute Hypercapnic Respiratory Failure (AHRF). This study will also provide a comparative analysis of the costs and health consequences of two alternative strategies to inform decision making about healthcare. All interventions are individually evidence-based and seem sound to hypothesize that implementing such interventions might improve patient's outcome and reduce the financial burder of repeated hospitalization in AHRF survivors.

Registry
clinicaltrials.gov
Start Date
May 28, 2018
End Date
July 31, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
CTU
Responsible Party
Sponsor Investigator
Principal Investigator

CTU

Principal investigator

University Hospital, Geneva

Eligibility Criteria

Inclusion Criteria

  • Consent form signed
  • Acute hypercapnic respiratory failure defined as PaCO2 \> 6.3 kPa requiring invasive or non-invasive mechanical ventilation in the ICU

Exclusion Criteria

  • Age \< 18 years old
  • Known or suspected neuromuscular diseases
  • Pregnancy
  • Iatrogenic respiratory failure (i.e. drug overdose, AHRF after starting opiates or increasing opiates dose)
  • Life expectancy \< 3 months
  • Confusion or major psychiatric illness
  • Patient unable to be weaned from NIV

Outcomes

Primary Outcomes

Hospital readmission

Time Frame: 1-year observation

Hospital or ICU readmission

Secondary Outcomes

  • Health Related Quality of Life(Measured at regular 3, 6 and 12 months visits following patient's hospital discharge)
  • Cost-effectiveness(1-year observation)

Study Sites (3)

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