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
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|
|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|
- Procedure: Emergency abdominal surgery
Emergency surgery for high-risk abdominal pathology using a protocol for optimized perioperative care
- Short term mortality [ Time Frame: 30 days ]30 day mortality after surgery
- Long-term mortality [ Time Frame: 180 days ]180-day mortality after surgery
- Length of hospitalization [ Time Frame: From primary surgery until 6 months after surgery ]Length of hospitalization after surgery
- Length of intensive care admission [ Time Frame: From primary surgery until 6 months after surgery ]Leghth of stay at ICU
- 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.
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
|Contact: Rune Hasselager, M.D.||firstname.lastname@example.org|
|Hvidovre University hospital||Recruiting|
|Hvidovre, Capital Region, Denmark, 2650|
|Contact: Nicolai B Foss, DMSc Nicolai.Bang.Foss@regionh.dk|
|Principal Investigator:||Nicolai B Foss, DMSc||Department of Anaesthesiology and Intensive Care, Hvidovre University Hospital, Denmark|