Clinical trial NCT01209663: Intermediate Care - Effect on Mortality Following Emergency Abdominal Surgery
Official title: Intermediate Care - Effect on Mortality Following Emergency Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Emergency Abdominal Surgery
Keywords: General Surgery
Emergency treatment
Postoperative care
Intermediate care unit
High dependency unit
Mortality
Lead sponsor: Copenhagen University Hospital at Herlev
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
name: Copenhagen Trial Unit, Center for Clinical Intervention Research
name: Herlev Hospital
name: Sygekassernes Helsefond
name: Danish Council for Independent Research
name: AP Moeller Foundation
name: Lundbeck Foundation
name: Hilleroed Hospital
name: Zealand University Hospital
name: Bispebjerg Hospital
name: Herning Hospital
name: Aabenraa Hospital
name: Vejle Hospital
First posted: 2010-09-27
Enrollment: 286
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Emergency laparotomy patients treated by general surgeons OR
* Emergency laparoscopic surgery patients treated by general surgeons OR
* Re-operative patients who go through emergency laparotomy or laparoscopy.

AND

* APACHE II score ≥ 10 AND
* Patients who are ready to be discharged to the surgical ward after postoperative stay in the recovering unit or an intermediate/intensive care bed

Exclusion Criteria:

* Appendectomy
* Emergency laparoscopic cholecystectomy
* Emergency diagnostic laparoscopy without intervention
* Postoperative stay in the recovery unit or an intermediate/intensive care bed in more then 24 hours before randomization
* Patients who should not be offered postoperative intensive care
* Patients who have been included in the study earlier
* Age \< 18 years
* Trauma patients

Because of slower enrolment rate than anticipated the steering committee have decided on the 3rd of May 2012 to include patients with Apache II score of 10 and 11 although the originally inclusion criteria was Apache II score 12 or above. Patients with Apache II score of 10 and 11 have a high 30 day mortality as well and the potential to benefit from intermediate care. The new criteria was initiated on the 23rd of May 2012 after ethical approval was obtained.

Primary outcomes:
measure: All cause mortality rate
timeFrame: Within 30 days of surgery
Secondary outcomes:
measure: long term mortality
timeFrame: Until 30 days after the last patient is enrolled in the trial
measure: rate of critical care unit admission from ward
timeFrame: Within 30 days of surgery
measure: Postoperative hospitalization time
timeFrame: until 30 days after the last patient is enrolled in the trial
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen University, Bispebjerg Hospital
state: DK
city: Herning
country: Denmark
facility: Herning Regional Hospital
state: DK
city: Aabenraa
country: Denmark
facility: Aabenraa Hospital
city: Copenhagen
country: Denmark
facility: Herlev University Hospital
city: Hilleroed
country: Denmark
facility: Copehagen University, Hilleroed Hospital
city: Koege
country: Denmark
facility: Copenhagen University, Koege Hospital
city: Vejle
country: Denmark
facility: Sygehus Lillebaelt, Vejle Hospital
Study officials:
affiliation: Department of Anaesthesiology and Intensive Care Medicine, Copenhagen University Hospital Herlev
name: Morten Vester-Andersen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Anaesthesiology and Intensive Care Medicine, Copenhagen University Hospital Herlev
name: Ann M Møller, MD, PhD
role: STUDY_CHAIR
affiliation: Copenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen University Rigshospitalet
name: Jørn Wetterslev, MD, PhD
role: STUDY_CHAIR
affiliation: Department of Gastrointestinal Surgery, Copenhagen University Hospital Herlev
name: Jacob Rosenberg, MD, Prof
role: STUDY_CHAIR
affiliation: Department of Anaesthesiology and Intensive Care Medicine, Copenhagen University Hospital Herlev
name: Tina Waldau, MD, PhD
role: STUDY_CHAIR
affiliation: Department of Anaesthesiology and Intensive Care Medicine, Copenhagen University Hospital Bispebjerg
name: Morten H Møller, MD, PhD
role: STUDY_CHAIR
affiliation: Department of Gastrointestinal Surgery, Copenhagen University Hospital Herlev
name: Flemming Moesgaard, MD, PhD
role: STUDY_CHAIR
affiliation: Department of Gastrointestinal Surgery, Copenhagen University Hospital Bispebjerg
name: Lars N Jørgensen, MD, Prof.
role: STUDY_CHAIR
References:
citation: Vester-Andersen M, Waldau T, Wetterslev J, Moller MH, Rosenberg J, Jorgensen LN, Jakobsen JC, Moller AM; InCare trial group. Randomized multicentre feasibility trial of intermediate care versus standard ward care after emergency abdominal surgery (InCare trial). Br J Surg. 2015 May;102(6):619-29. doi: 10.1002/bjs.9749. Epub 2015 Mar 18.
citation: Vester-Andersen M, Waldau T, Wetterslev J, Moller MH, Rosenberg J, Jorgensen LN, Gillesberg I, Jakobsen HL, Hansen EG, Poulsen LM, Skovdal J, Sogaard EK, Bestle M, Vilandt J, Rosenberg I, Berthelsen RE, Pedersen J, Madsen MR, Feurstein T, Busse MJ, Andersen JD, Maschmann C, Rasmussen M, Jessen C, Bugge L, Ording H, Moller AM. Effect of intermediate care on mortality following emergency abdominal surgery. The InCare trial: study protocol, rationale and feasibility of a randomised multicentre trial. Trials. 2013 Feb 2;14:37. doi: 10.1186/1745-6215-14-37.