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Trial record 1 of 1 for:    NCT03167580
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REstricted Versus Liberal Positive End-Expiratory Pressure in Patients Without ARDS (RELAx)

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ClinicalTrials.gov Identifier: NCT03167580
Recruitment Status : Completed
First Posted : May 30, 2017
Last Update Posted : March 31, 2020
Sponsor:
Collaborators:
ZonMw: The Netherlands Organisation for Health Research and Development
Amphia Hospital
Gelre Hospitals
Isala
Maastricht University Medical Center
Medical Center Haaglanden
Onze Lieve Vrouwe Gasthuis
St. Antonius Hospital
VU University Medical Center
Dijklander Ziekenhuis
Spaarne Gasthuis
HagaZiekenhuis
Rijnstate Hospital
Information provided by (Responsible Party):
Prof. Dr. Marcus J. Schultz, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief Summary:
The 'REstricted versus Liberal positive end-expiratory pressure in patients without Acute respiratory distress syndrome' (RELAx) trial is a national multicenter, open randomized controlled trial in ICU patients without ARDS at start of ventilation. It will be the first RCT comparing ventilation with the lowest possible positive end-expiratory pressure (PEEP) level with ventilation with the median PEEP level currently practiced in the Netherlands that recruits a sufficient number of patients to test the hypothesis that ventilation with the lowest possible PEEP level is non-inferior to ventilation with a PEEP level of 8 cm H2O with regard to objective and patient-relevant clinical endpoints.

Condition or disease Intervention/treatment Phase
Ventilator-free Days Procedure: restricted PEEP Procedure: liberal PEEP Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 980 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Assignment
Masking: None (Open Label)
Masking Description: Open Label
Primary Purpose: Treatment
Official Title: REstricted Versus Liberal Positive End-Expiratory Pressure in Patients Without Acute Respiratory Distress Syndrome
Actual Study Start Date : October 26, 2017
Actual Primary Completion Date : January 14, 2020
Actual Study Completion Date : March 16, 2020


Arm Intervention/treatment
Experimental: Ventilation with restricted PEEP level
Use of the restricted PEEP level (0 - 5 cm H2O, the lowest possible PEEP level) after intubation and during all mechanical ventilation.
Procedure: restricted PEEP
Patients are randomized and ventilated with restricted PEEP (the lowest possible PEEP level, 0 - 5 cm H2O)

Active Comparator: Ventilation with liberal PEEP Level
Use of the liberal PEEP level (8 cm H2O) after intubation and during all mechanical ventilation.
Procedure: liberal PEEP
Patients are randomized and ventilated with liberal PEEP (the median PEEP level used in the Netherlands, 8 cm H2O)




Primary Outcome Measures :
  1. Ventilation-free days and alive at day 28 [ Time Frame: first 28 days after start of ventilation ]
    The number of ventilation-free days, defined as the number of days from day 1 to day 28; the patient is alive and breathes without assistance of the mechanical ventilator, if the period of unassisted breathing lasted at least 24 consecutive hours.


Secondary Outcome Measures :
  1. Length of stay [ Time Frame: first 90 days after start of ventilation ]
    Length of stay in the intensive care unit and in the hospital

  2. Mortality [ Time Frame: first 90 days after start of ventilation ]
    Any death during ICU-, hospital-stay and within 90 days

  3. Pulmonary complications [ Time Frame: daily until detubation or day 28 ]
    development of ARDS according tot the Berlin definition, severe hypoxemia, severe atelectasis, severe atelectasis, pneumonia and pneumothorax.

  4. Rescue strategies for severe hypoxemia or severe atelectasis [ Time Frame: daily until detubation or day 28 ]
    Recruitment maneuver, prone positioning and bronchoscopy for opening atelectasis.

  5. Days with use of hemodynamic support [ Time Frame: daily until detubation or day 28 ]
    The number of ICU days with any use of vasopressors/inotropes for > 2 hours on a day.

  6. Days with use of sedation [ Time Frame: daily until detubation or day 28 ]
    Defined as the number of ICU days with any use of sedatives for > 2 hours on a day.

  7. Therapeutic intervention scoring system (TISS)/ Nursing Activities Score (NAS) [ Time Frame: daily until detubation or day 28 ]
    Incremental Cost Effectiveness Ratios (ICER) will be calculated by extra costs per TISS/NAS point, a valuable score reflecting workload and resource utilization in daily ICU practice.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Admission to one of the participating ICUs
  • Need for and start of invasive ventilation
  • An expected duration of ventilation > 24 hours

Exclusion Criteria:

  • Age less than 18 years
  • Patients with a clinical diagnosis of ARDS or possible ARDS with a PaO2/FiO2 < 200 mmHg (as the benefit of ventilation with higher PEEP levels has been proven in these patients)
  • Patients with ongoing cardiac ischemia due to cardiac infarction and failed revascularization, patients with increased and uncontrollable intracranial pressure (of ≥ 18 mmHg), patients with delayed cerebral ischemia after subarachnoid hemorrhage, patients with necrotizing fasciitis, and severe untreatable anemia such as in case of Jehovah's Witnesses (as these patients can be considered to be vulnerable to the potentially dangerous hypoxemia which could develop more often, even for a short time, in the 'restricted PEEP'-arm of this trial)
  • Patients previously randomized in this RCT
  • Patients participating in another RCT with the same clinical endpoint, or interventions possibly compromising the primary outcome
  • Invasive ventilation longer than 12 hours directly preceding the present ICU admission
  • Invasive ventilation longer than 1 hour before randomization
  • Patients with suspected or confirmed pregnancy
  • Patients with morbid obesity (body mass index > 40)
  • Patients with GOLD classification III or IV chronic obstructive pulmonary disease (COPD)
  • Patients with premorbid restrictive pulmonary disease (evidence of chronic interstitial infiltration on chest radiographs)
  • Patients in whom pulse oximetry is known to be unreliable, e.g., patients with carbon monoxide poisoning
  • Any neurologic diagnosis that can prolong duration of mechanical ventilation, e.g., patients with Guillain-Barré syndrome, high spinal cord lesion or amyotrophic lateral sclerosis, multiple sclerosis, or myasthenia gravis
  • No informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03167580


Locations
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Netherlands
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Amsterdam, Netherlands
Onze Lieve Vrouwe Gasthuis
Amsterdam, Netherlands
VU Medical Center
Amsterdam, Netherlands
Gelre Hospital
Apeldoorn, Netherlands
Rijnstate
Arnhem, Netherlands
Amphia Hospital
Breda, Netherlands
Spaarne Gasthuis
Hoofddorp, Netherlands
Westfriesgasthuis
Hoorn, Netherlands
Maastricht University Medical Center
Maastricht, Netherlands
Sint Antonius Hospital
Nieuwegein, Netherlands
Haaglanden Medical Center
the Hague, Netherlands
HagaZiekenhuis
The Hague, Netherlands
Isala Clinics
Zwolle, Netherlands
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ZonMw: The Netherlands Organisation for Health Research and Development
Amphia Hospital
Gelre Hospitals
Isala
Maastricht University Medical Center
Medical Center Haaglanden
Onze Lieve Vrouwe Gasthuis
St. Antonius Hospital
VU University Medical Center
Dijklander Ziekenhuis
Spaarne Gasthuis
HagaZiekenhuis
Rijnstate Hospital
Investigators
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Principal Investigator: Marcus J. Schultz, MD, PhD Department of Intensive Care, Academic Medical Center
Principal Investigator: Frederique Paulus, PhD Department of Intensive Care, Academic Medical Center
  Study Documents (Full-Text)

Documents provided by Prof. Dr. Marcus J. Schultz, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
Statistical Analysis Plan  [PDF] August 27, 2019
Study Protocol  [PDF] December 6, 2019

Additional Information:
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Prof. Dr. Marcus J. Schultz, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT03167580    
Other Study ID Numbers: RELAx
First Posted: May 30, 2017    Key Record Dates
Last Update Posted: March 31, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No