Emergency Abdominal Surgery Clinical Trial
Official title:
Intermediate Care - Effect on Mortality Following Emergency Abdominal Surgery
The objective of this trial is to evaluate postoperative intermediate care versus ward care
in patients who have undergone emergency abdominal surgery with a perioperative Acute
Physiology and Chronic Health Evaluation (APACHE) II score ≥ 10 (high risk patients).
Patients will be enrolled in the trial, if they are ready to be discharged from the recovery
unit or intensive/intermediate care unit to the surgical ward within 24 hours after surgery.
Discharge criteria will be according to the Danish national recommendation.
The intermediate care bed in the trial is defined by a certain minimum requirements to
patient observation and described treatment possibilities which have to be available to the
intermediate bed. If the treatment exceeds these treatment possibilities, the patient will
be classified as an intensive care patient. The intermediate care bed will be placed at an
intensive care unit, recovery unit or a surgical high dependency unit. If there is no
available intermediate care bed, the patients will not be randomized, but only registered as
"excluded because of no available intermediate care bed".
Hypothesis: Postoperative intermediate care for 48 hours or more will reduce the 30-day
mortality in emergency abdominal surgery patients with a high risk of postoperative organ
failure.
Interim analysis: An independent Data Monitoring and Safety Committee (DMSC) will conducted
the interim analysis based on the analysis of the primary outcome blinded for intervention
allocation. The DMSC will use P<0.001 (Haybittle-Peto) on two subsequent interim analyses as
the statistical limit to guide its recommendations regarding early termination of the trial
for benefit or harm. The first interim analysis will be conducted when the 30 days follow-up
data of about 50% (i.e., about 200 patients) of the trial participants have been obtained
and/or 75 deaths have been documented during the trial. If P<0,001 in the first interim
analysis a second interim analysis will be conducted when the 30 days follow-up data of
about 75% (i.e., about 300 patients) of the trial participants have been obtained and/or 25
deaths have been documented during the trial.
Trial terminated on the 30th November 2012. The Data Monitor Committee found a very low
overall event rate of the primary outcome at the first interim-analysis as compared to the
pre-trial estimated. This precluding any possibility to detect or reject the anticipated
relative risk reduction of 34 % as used in the sample size estimation.
Like Denmark, many European countries has only limited access to surgical intermediate care beds (high dependency beds). This may reflect lack of scientific evidence for the effect of intermediate care combined with restricted healthcare resources. Better access to dedicated postoperative intensive/intermediate care facilities has been suggested as a factor which potentially can reduce postoperative complication rate and mortality in high risk surgical patients. The Incare Trial will provide important data on the effect of postoperative intermediate care in emergency abdominal surgery patients. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT02892435 -
Prevena™ Incision Management System vs Conventional Management for Wound Healing
|
Phase 2 | |
| Completed |
NCT03987789 -
Intraoperative Protective Mechanical Ventilation in Patients Requiring Emergency Abdominal Surgery
|
N/A |