Intermediate Care - Effect on Mortality Following Emergency Abdominal Surgery

NCT01209663 | Terminated DMC

• 1 other identifier: H-3-2010-010
• Study Type: interventional
• Target: 286
• Locations: 1 country
• Sites: 7

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.

Conditions

Emergency Abdominal Surgery

Keywords

General Surgery; Emergency treatment; Postoperative care; Intermediate care unit; High dependency unit; Mortality

Outcome Measures

Primary Outcomes (1)

• All cause mortality rate

  Within 30 days of surgery

Secondary Outcomes (3)

• long term mortality

  Until 30 days after the last patient is enrolled in the trial

• rate of critical care unit admission from ward

  Within 30 days of surgery

• Postoperative hospitalization time

  until 30 days after the last patient is enrolled in the trial

Study Arms (2)

Ward Care

ACTIVE COMPARATOR

Protocol based discharge to the surgery ward. Observation and treatment is conducted by ward nurses and general surgeons (current treatment).

Other: Postoperative Intermediate Care

Intermediate Care

EXPERIMENTAL

Observation and treatment in an intermediate care bed in a minimum of 48 hours after randomization. Daily rounds will be carried out by both general surgeons and intensive care physicians.

Other: Postoperative Intermediate Care

Interventions

Postoperative Intermediate Care OTHER

Comparison of postoperative Intermediate Care versus Ward Care.

Also known as: High dependency bed, High dependency unit

Intermediate Care; Ward Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Copenhagen University Hospital at Herlev: lead
• University of Copenhagen: collaborator
• Copenhagen Trial Unit, Center for Clinical Intervention Research: collaborator
• Herlev Hospital: collaborator
• Sygekassernes Helsefond: collaborator
• Danish Council for Independent Research: collaborator
• AP Moeller Foundation: collaborator
• Lundbeck Foundation: collaborator
• Hilleroed Hospital: collaborator
• Zealand University Hospital: collaborator
• Bispebjerg Hospital: collaborator
• Herning Hospital: collaborator
• Aabenraa Hospital: collaborator
• Vejle Hospital: collaborator

Study Sites (7)

Copenhagen University, Bispebjerg Hospital

Copenhagen, DK, 2400, Denmark

Location

Herning Regional Hospital

Herning, DK, 7400, Denmark

Location

Aabenraa Hospital

Aabenraa, DK-6200, Denmark

Location

Herlev University Hospital

Copenhagen, DK-2730, Denmark

Location

Copehagen University, Hilleroed Hospital

Hilleroed, DK-3400, Denmark

Location

Copenhagen University, Koege Hospital

Koege, DK-4600, Denmark

Location

Sygehus Lillebaelt, Vejle Hospital

Vejle, DK-7100, Denmark

Location

Related Publications (2)

• 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.

  PMID: 25789827 DERIVED

• 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.

  PMID: 23374977 DERIVED

Study Officials

• Morten Vester-Andersen, MD

  Department of Anaesthesiology and Intensive Care Medicine, Copenhagen University Hospital Herlev

  PRINCIPAL INVESTIGATOR

• Ann M Møller, MD, PhD

  Department of Anaesthesiology and Intensive Care Medicine, Copenhagen University Hospital Herlev

  STUDY CHAIR

• Jørn Wetterslev, MD, PhD

  Copenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen University Rigshospitalet

  STUDY CHAIR

• Jacob Rosenberg, MD, Prof

  Department of Gastrointestinal Surgery, Copenhagen University Hospital Herlev

  STUDY CHAIR

• Tina Waldau, MD, PhD

  Department of Anaesthesiology and Intensive Care Medicine, Copenhagen University Hospital Herlev

  STUDY CHAIR

• Morten H Møller, MD, PhD

  Department of Anaesthesiology and Intensive Care Medicine, Copenhagen University Hospital Bispebjerg

  STUDY CHAIR

• Flemming Moesgaard, MD, PhD

  Department of Gastrointestinal Surgery, Copenhagen University Hospital Herlev

  STUDY CHAIR

• Lars N Jørgensen, MD, Prof.

  Department of Gastrointestinal Surgery, Copenhagen University Hospital Bispebjerg

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Senior resident

Study Record Dates

• First Submitted: September 24, 2010
• First Posted: September 27, 2010
• Study Start: October 1, 2010
• Primary Completion: November 1, 2012
• Study Completion: December 1, 2012
• Last Updated: June 24, 2015

Record last verified: 2015-06

Locations

DK (7)