Emergency Abdominal SurgeryInCareNCT01209663
Intermediate Care - Effect on Mortality Following Emergency Abdominal Surgery
A study testing Postoperative Intermediate Care in people with Emergency Abdominal Surgery, run by Copenhagen University Hospital at Herlev at 7 sites in Denmark.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emergency Abdominal Surgery
- What is being tested?
- Postoperative Intermediate Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 286 participants
- Where
- 7 sitesDenmark
- Study dates
- Oct 2010to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Denmark7 sites
Aabenraa Hospital
Aabenraa, DK-6200
Copenhagen University, Bispebjerg Hospital
Copenhagen, DK, 2400
Herlev University Hospital
Copenhagen, DK-2730
Herning Regional Hospital
Herning, DK, 7400
Copehagen University, Hilleroed Hospital
Hilleroed, DK-3400
Copenhagen University, Koege Hospital
Koege, DK-4600
Sygehus Lillebaelt, Vejle Hospital
Vejle, DK-7100
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Emergency Abdominal Surgery
- Being tested
- Postoperative Intermediate Care
- Keywords
- General Surgery, Emergency treatment, Postoperative care, Intermediate care unit, High dependency unit, Mortality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postoperative Intermediate CareOther
Also called High dependency bed, High dependency unit
Comparison of postoperative Intermediate Care versus Ward Care.
| Study group | Role | What they receive |
|---|---|---|
| Ward Care | Active comparator | Protocol based discharge to the surgery ward. Observation and treatment is conducted by ward nurses and general surgeons (current treatment). Receives: 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. Receives: Other: Postoperative Intermediate Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality rate
Measured: Within 30 days of surgery
Secondary outcomes (3)
long term mortality
Measured: Until 30 days after the last patient is enrolled in the trial
rate of critical care unit admission from ward
Measured: Within 30 days of surgery
Postoperative hospitalization time
Measured: until 30 days after the last patient is enrolled in the trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2010 (estimated)
- Study startOct 2010
- Primary completionNov 2012
- Study completionDec 2012
Why it stopped: 30th November 2012. Please see breif summary.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Emergency Abdominal SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 286 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital at Herlev
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen, Copenhagen Trial Unit, Center for Clinical Intervention Research, Herlev Hospital, Sygekassernes Helsefond, Danish Council for Independent Research, AP Moeller Foundation, Lundbeck Foundation, Hilleroed Hospital, Zealand University Hospital, Bispebjerg Hospital, Herning Hospital, Aabenraa Hospital, Vejle Hospital
- Responsible party
- Principal investigator, Morten Vester-Andersen, Copenhagen University Hospital at Herlev
- Investigators
- Morten Vester-Andersen, MD, Principal investigator, Department of Anaesthesiology and Intensive Care Medicine, Copenhagen University Hospital HerlevAnn M Møller, MD, PhD, Study chair, Department of Anaesthesiology and Intensive Care Medicine, Copenhagen University Hospital HerlevJørn Wetterslev, MD, PhD, Study chair, Copenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen University RigshospitaletJacob Rosenberg, MD, Prof, Study chair, Department of Gastrointestinal Surgery, Copenhagen University Hospital HerlevTina Waldau, MD, PhD, Study chair, Department of Anaesthesiology and Intensive Care Medicine, Copenhagen University Hospital HerlevMorten H Møller, MD, PhD, Study chair, Department of Anaesthesiology and Intensive Care Medicine, Copenhagen University Hospital BispebjergFlemming Moesgaard, MD, PhD, Study chair, Department of Gastrointestinal Surgery, Copenhagen University Hospital HerlevLars N Jørgensen, MD, Prof., Study chair, Department of Gastrointestinal Surgery, Copenhagen University Hospital Bispebjerg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01209663
- Sponsor's protocol ID
- H-3-2010-010
- Acronym
- InCare
- Status last verified
- Jun 2015
- First submitted
- 24 Sep 2010
- Last updated
- 24 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25789827Vester-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.
PubMed 23374977
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermediate Care - Effect on Mortality Following Emergency Abdominal Surgery
- ClinicalTrials.gov ID
- NCT01209663
- Acronym / sponsor ID
- InCare / H-3-2010-010
- Conditions
- Emergency Abdominal Surgery
- Keywords
- General Surgery, Emergency treatment, Postoperative care, Intermediate care unit, High dependency unit, Mortality
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 30th November 2012. Please see breif summary.
- Enrolment
- 286 participants (actual)
- Lead sponsor
- Copenhagen University Hospital at HerlevUniversity, hospital or other
- Collaborators
- University of Copenhagen, Copenhagen Trial Unit, Center for Clinical Intervention Research, Herlev Hospital, Sygekassernes Helsefond, Danish Council for Independent Research, AP Moeller Foundation, Lundbeck Foundation, Hilleroed Hospital, Zealand University Hospital, Bispebjerg Hospital, Herning Hospital, Aabenraa Hospital, Vejle Hospital
- Study start
- Oct 2010
- Primary completion
- Nov 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 27 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ward Care | Active comparator | Other: Postoperative Intermediate CareProtocol based discharge to the surgery ward. Observation and treatment is conducted by ward nurses and general surgeons (current treatment). |
| Intermediate Care | Experimental | Other: Postoperative Intermediate CareObservation 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Postoperative Intermediate CareAlso: High dependency bed, High dependency unitComparison of postoperative Intermediate Care versus Ward Care. | Other | Intermediate Care, Ward Care |
Primary outcome
All cause mortality rate
Time frame: Within 30 days of surgery
3 secondary outcomes
long term mortality
Time frame: Until 30 days after the last patient is enrolled in the trial
rate of critical care unit admission from ward
Time frame: Within 30 days of surgery
Postoperative hospitalization time
Time frame: until 30 days after the last patient is enrolled in the trial
Results and safety
The study was stopped early (reason given: 30th November 2012. Please see breif summary.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2015.
- Derived from this study: PubMed 25789827Vester-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.
- Derived from this study: PubMed 23374977Vester-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Morten Vester-Andersen, MD principal investigator
Department of Anaesthesiology and Intensive Care Medicine, Copenhagen University Hospital Herlev
Ann M Møller, MD, PhD study chair
Department of Anaesthesiology and Intensive Care Medicine, Copenhagen University Hospital Herlev
Jørn Wetterslev, MD, PhD study chair
Copenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen University Rigshospitalet
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postoperative Intermediate Care in people with Emergency Abdominal Surgery, run by Copenhagen University Hospital at Herlev at 7 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: 30th November 2012. Please see breif summary.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All cause mortality rate (time frame: Within 30 days of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01209663, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2015.