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Biomarkers in Acute High-risk AbdoMinAl Surgery (BAHAMAS)

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ClinicalTrials.gov Identifier: NCT03582631
Recruitment Status : Recruiting
First Posted : July 11, 2018
Last Update Posted : July 12, 2018
Sponsor:
Collaborator:
Hvidovre University Hospital
Information provided by (Responsible Party):
Rune Børch Hasselager, University of Copenhagen

Brief Summary:

Acute high-risk abdominal surgery (AHA) is performed in hospitals worldwide. Ethiologies are heterogeneous, but it carries a high mortality rate (1)(2). In particular, emergency laparotomies performed on elderly people has a high mortality rate(3)(4). Different quality improvement programs have been suggested, but the quality of care and mortality varies between hospitals (5)(6). The use of postoperative intensive care seem to be inadequate for this high risk population (1)(7)(8). It is of paramount importance to identify the frailest and acutely deranged patients, who are in risk of poor outcome, to allocate resources for optimization postoperatively. Failure to escalate care intensity after having developed postoperative complications affect outcome. Organization, teamwork and culture is important postoperatively to be able to escalate care especially in standard care wards (9)(10). However, it is difficult to predict which patients will develop complications.

Different risk assessment tools have been proposed for patients undergoing AHA (11)(12). The APACHE-II score, even though developed for critical care, seems to give the best prediction of outcome. Objective risk assessment tools support clinical decision making as subjective clinical assessment often underestimates the risk for the patients in highest risk of complications and death (13). Good clinical decision-making is likely to improve the clinical outcome by allocating appropriate resources. Prognostic tools are also useful to inform patients about what to expect in the postoperative phase and of long-term outcome. Especially in the elder population with increased risk of loss of function or independency, this can be useful to give informed consent to treatment. Furthermore, good risk assessment is important to optimize palliative care after end-of-life decisions, which is often ignored in research, but highly relevant in clinical work.

Prognostic biomarkers in other high mortality populations have received much attention for risk stratification (14). An ideal biomarker should be readily available upon decision-making, easy to measure, and reliable. Furthermore, it should accurately differentiate prognosis for patients to have value in the clinical decision-making and guide the treatment. It should also be linked to the clinical outcomes.

The investigators aim to identify AHA biomarkers that are prognostic or predictive for postoperative morbidity, mortality and length of hospitalization.


Condition or disease Intervention/treatment
General Surgery Inflammation Troponins Biomarkers Procedure: Emergency abdominal surgery

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Biomarkers in Acute High-risk AbdoMinAl Surgery
Actual Study Start Date : June 1, 2013
Estimated Primary Completion Date : May 1, 2022
Estimated Study Completion Date : May 1, 2022

Intervention Details:
  • Procedure: Emergency abdominal surgery
    Emergency surgery for high-risk abdominal pathology using a protocol for optimized perioperative care


Primary Outcome Measures :
  1. Short term mortality [ Time Frame: 30 days ]
    30 day mortality after surgery

  2. Long-term mortality [ Time Frame: 180 days ]
    180-day mortality after surgery


Secondary Outcome Measures :
  1. Length of hospitalization [ Time Frame: From primary surgery until 6 months after surgery ]
    Length of hospitalization after surgery

  2. Length of intensive care admission [ Time Frame: From primary surgery until 6 months after surgery ]
    Leghth of stay at ICU

  3. Perioperative need of vasopressors [ Time Frame: From primary surgery until 6 months after surgery ]
    perioperative need for inotropic or vasopressor support and high volume fluid resuscitation


Biospecimen Retention:   Samples Without DNA

Blood samples were collected at the time of induction of anaesthesia. For AHA-patients a pre-operative optimisation protocol was introduced in the hospital throughout the data collection period, which stated that the patient was optimized with goal directed fluid therapy before induction of anaesthesia. The blood samples were usually taken from the arterial line used for invasive blood pressure monitoring but some were obtained from venous puncture with standard preoperative tests.

The blood samples were collected in tubes with EDTA as anti-coagulant for plasma and in tubes with coagulation enhancer for serum. After centrifugation for 10 mins at room temperature the plasma and serum, respectively were transferred to freezing tubes for subsequent long-term storage at -80C.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population

Include patients with a preoperative blood sample stored in the bio bank; the patients did undergo AHA at Hvidovre Hospital, Copenhagen, Denmark, from June 1st 2013 when the AHA study protocol was initiated.

In the primary study we will include the first 100 consecutive primary operations in the cohort.

Criteria

Inclusion Criteria:

  • Patients aged 18 or older with the suspicion for abdominal pathology requiring immediate emergency laparotomy or laparoscopy including reoperations after elective surgery and reoperations after previous AHA surgery.

Exclusion Criteria:

  • We excluded the following procedures: appendectomies; negative laparoscopies and laparotomies; cholecystectomies; simple herniotomies following incarceration (without intestinal resection); reoperation due to fascial separation with no other abdominal pathology; internal herniation after roux-en-y gastric bypass surgery; sub-acute surgery (planned within 48 hours) for inflammatory bowel disease; and sub-acute colorectal cancer surgery.

We excluded, traumas, pregnant woman, uro-genital, gynaecological and vascular pathology except for mesenteric ischemia.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03582631


Contacts
Contact: Rune Hasselager, M.D. 004531104653 runehasselager@gmail.com

Locations
Denmark
Hvidovre University hospital Recruiting
Hvidovre, Capital Region, Denmark, 2650
Contact: Nicolai B Foss, DMSc       Nicolai.Bang.Foss@regionh.dk   
Sponsors and Collaborators
University of Copenhagen
Hvidovre University Hospital
Investigators
Principal Investigator: Nicolai B Foss, DMSc Department of Anaesthesiology and Intensive Care, Hvidovre University Hospital, Denmark
  Study Documents (Full-Text)

Documents provided by Rune Børch Hasselager, University of Copenhagen:

Publications:

Responsible Party: Rune Børch Hasselager, Principal Investigator, Medical Doctor, University of Copenhagen
ClinicalTrials.gov Identifier: NCT03582631     History of Changes
Other Study ID Numbers: BAHAMAS1
First Posted: July 11, 2018    Key Record Dates
Last Update Posted: July 12, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Inflammation
Pathologic Processes