Intermediate Care - Effect on Mortality Following Emergency Abdominal Surgery
NCT ID: NCT01209663
Last Updated: 2015-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
286 participants
INTERVENTIONAL
2010-10-31
2012-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Ward Care
Protocol based discharge to the surgery ward. Observation and treatment is conducted by ward nurses and general surgeons (current treatment).
Postoperative Intermediate Care
Comparison of postoperative Intermediate Care versus Ward Care.
Intermediate Care
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.
Postoperative Intermediate Care
Comparison of postoperative Intermediate Care versus Ward Care.
Interventions
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Postoperative Intermediate Care
Comparison of postoperative Intermediate Care versus Ward Care.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University of Copenhagen
OTHER
Copenhagen Trial Unit, Center for Clinical Intervention Research
OTHER
Herlev Hospital
OTHER
Sygekassernes Helsefond
OTHER
Danish Council for Independent Research
OTHER
AP Moeller Foundation
OTHER
Lundbeck Foundation
OTHER
Hilleroed Hospital
UNKNOWN
Zealand University Hospital
OTHER
Bispebjerg Hospital
OTHER
Herning Hospital
OTHER
Aabenraa Hospital
OTHER
Vejle Hospital
OTHER
Copenhagen University Hospital at Herlev
OTHER
Responsible Party
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Morten Vester-Andersen
MD, Senior resident
Principal Investigators
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Morten Vester-Andersen, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Anaesthesiology and Intensive Care Medicine, Copenhagen University Hospital Herlev
Ann M Møller, MD, PhD
Role: STUDY_CHAIR
Department of Anaesthesiology and Intensive Care Medicine, Copenhagen University Hospital Herlev
Jørn Wetterslev, MD, PhD
Role: STUDY_CHAIR
Copenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen University Rigshospitalet
Jacob Rosenberg, MD, Prof
Role: STUDY_CHAIR
Department of Gastrointestinal Surgery, Copenhagen University Hospital Herlev
Tina Waldau, MD, PhD
Role: STUDY_CHAIR
Department of Anaesthesiology and Intensive Care Medicine, Copenhagen University Hospital Herlev
Morten H Møller, MD, PhD
Role: STUDY_CHAIR
Department of Anaesthesiology and Intensive Care Medicine, Copenhagen University Hospital Bispebjerg
Flemming Moesgaard, MD, PhD
Role: STUDY_CHAIR
Department of Gastrointestinal Surgery, Copenhagen University Hospital Herlev
Lars N Jørgensen, MD, Prof.
Role: STUDY_CHAIR
Department of Gastrointestinal Surgery, Copenhagen University Hospital Bispebjerg
Locations
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Copenhagen University, Bispebjerg Hospital
Copenhagen, DK, Denmark
Herning Regional Hospital
Herning, DK, Denmark
Aabenraa Hospital
Aabenraa, , Denmark
Herlev University Hospital
Copenhagen, , Denmark
Copehagen University, Hilleroed Hospital
Hilleroed, , Denmark
Copenhagen University, Koege Hospital
Koege, , Denmark
Sygehus Lillebaelt, Vejle Hospital
Vejle, , Denmark
Countries
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References
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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.
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.
Other Identifiers
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H-3-2010-010
Identifier Type: -
Identifier Source: org_study_id
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