Ignite Creation Date:
2024-05-06 @ 2:04 AM
Last Modification Date:
2024-10-26 @ 11:13 AM
Study NCT ID:
NCT01967680
Status:
COMPLETED
Last Update Posted:
2018-04-06
First Post:
2013-10-18
Brief Title:
Non-sedation Versus Sedation With a Daily Wake-up Trial in Critically Ill Patients Receiving Mechanical Ventilation
Sponsor:
Palle Toft
Organization:
Odense University Hospital
Study Overview
Official Title:
Non-sedation Versus Sedation With a Daily Wake-up Trial in Critically Ill Patients Receiving Mechanical Ventilation The NONSEDA-trial An Investigator-initiated Randomised Clinical Parallel-group Multinational Superiority Trial
Status:
COMPLETED
Status Verified Date:
2018-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NONSEDA
Brief Summary:
Background Every year 30000 Danish patients are admitted to Intensive Care Units ICU accounting for 2-3 of all patients in hospital and 30 of the yearly hospital expenditure The mortality in the ICU is 127 and the 30-day mortality is 212 according to the national Danish Intensive Care Database Through many years the standard care has been to use continuous sedation of critically ill patients during me-chanical ventilation However recent research indicates that it is beneficial to reduce the sedation level in these patients A randomised trial found that continuous sedation with a daily wake-up trial compared to continuous sedation reduced the time on me-chanical ventilation and the length of stay in the intensive care unit Further a ran-domised trial comparing continuous sedation with a daily wake-up trial to no sedation found that patients in the non-sedated group needed mechanical ventilation for a shorter time and had a shorter length of stay in the ICU and in the hospital The trial also indicated a beneficial effect on mortality however the trial was not a priori de-signed or powered with respect to mortality No randomised trial has been published comparing sedation with no sedation a priori powered to have all-cause mortality as primary outcome
Objective To assess the benefits and harms of non-sedation versus sedation with a daily wake-up trial in critically ill patients in ICU
Design The NONSEDA trial is an investigator-initiated randomised clinical parallel-group multinational superiority trial designed to include 700 patients from at least six ICUs in Denmark Norway and Sweden
Inclusion criteria Mechanically ventilated patients with expected duration of me-chanical ventilation 24 hours
Exclusion criteria non-intubated patients patients with severe head trauma coma at admission or status epilepticus patients treated with therapeutic hypothermia patients with PaO2FiO29 where sedation might be necessary to ensure sufficient oxygenation or place the patient in prone position
Experimental intervention Non-sedation supplemented with pain management during mechanical ventilation
Control intervention Sedation with a daily wake-up trial
The primary hypothesis is that non-sedation compared to sedation and a daily wake-up trial will reduce mortality
The secondary hypotheses are that non-sedation compared to sedation and a daily wake-up trial will
Reduce the incidence of a composite outcome of death acute myocardial in-farction AMI stroke pulmonary embolism and other thromboembolic events
Reduce the number of organ failures
Increase the days alive without mechanical ventilation
Increase the days alive outside the ICU
Increase the days alive outside the hospital
Outcomes The primary outcome is all-cause mortality at 90 days Secondary out-comes are time to death in the trial period the frequency of the trombo-embolic com-plications acute renal failure days alive without mechanical ventilation days alive outside the ICU and hospital Explorative outcomes are mortality at 28 days organ failure and coma-free delirium-free days
Trial size The investigators will include 700 participants 2 x 350 in order to detect or reject 25 relative risk reduction in mortality with a type I error risk of 5 and a type II error risk of 20 power at 80
Objective To assess the benefits and harms of non-sedation versus sedation with a daily wake-up trial in critically ill patients in ICU
Design The NONSEDA trial is an investigator-initiated randomised clinical parallel-group multinational superiority trial designed to include 700 patients from at least six ICUs in Denmark Norway and Sweden
Inclusion criteria Mechanically ventilated patients with expected duration of me-chanical ventilation 24 hours
Exclusion criteria non-intubated patients patients with severe head trauma coma at admission or status epilepticus patients treated with therapeutic hypothermia patients with PaO2FiO29 where sedation might be necessary to ensure sufficient oxygenation or place the patient in prone position
Experimental intervention Non-sedation supplemented with pain management during mechanical ventilation
Control intervention Sedation with a daily wake-up trial
The primary hypothesis is that non-sedation compared to sedation and a daily wake-up trial will reduce mortality
The secondary hypotheses are that non-sedation compared to sedation and a daily wake-up trial will
Reduce the incidence of a composite outcome of death acute myocardial in-farction AMI stroke pulmonary embolism and other thromboembolic events
Reduce the number of organ failures
Increase the days alive without mechanical ventilation
Increase the days alive outside the ICU
Increase the days alive outside the hospital
Outcomes The primary outcome is all-cause mortality at 90 days Secondary out-comes are time to death in the trial period the frequency of the trombo-embolic com-plications acute renal failure days alive without mechanical ventilation days alive outside the ICU and hospital Explorative outcomes are mortality at 28 days organ failure and coma-free delirium-free days
Trial size The investigators will include 700 participants 2 x 350 in order to detect or reject 25 relative risk reduction in mortality with a type I error risk of 5 and a type II error risk of 20 power at 80
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None