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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03582631
Other study ID # BAHAMAS1
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2013
Est. completion date May 1, 2022

Study information

Verified date August 2022
Source University of Copenhagen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Acute high-risk abdominal surgery (AHA) is performed in hospitals worldwide. Ethiologies are heterogeneous, but overall emergency surgery carries a very high mortality rate (1)(2). In particular, emergency laparotomies performed on elderly people has a high mortality rate(3)(4). Different quality improvement programmes for that particular patient group have been suggested, but the quality of care and thereby mortality varies considerably between hospitals(5)(6). The use of postoperative intensive care and monitoring seem to be inadequate for this high risk population in a variety of hospitals(1)(7)(8). It is of paramount importance to identify the frailest and most acutely deranged patients, who are in risk of poor outcome, in order to allocate resources for improved monitoring and optimisation postoperatively. It has been shown that failure to rescue patients after having developed postoperative complications and inability to escalate care intensity affects the outcome. Organisation, teamwork and culture is important in the postoperative phase to be able to escalate care especially in standard care wards(9)(10). However, it is found difficult to predict which patients will experience complications in a standard care ward. 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 be the one with best prediction of outcome. Risk assessment tools are important to support clinical decision making by the perioperative team 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 immediate postoperative phase and of long-term outcome. Especially in the elder population with increased risk of long hospitalisation and loss of function or independency this can be useful to give informed consent to treatment strategy. 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. During recent years use of 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, reliable and biologically stable. Furthermore it has to be able to accurately differentiate prognosis for patients to have value in the clinical decision-making and guide the treatment of the patient. It should be linked to the clinical outcomes. The investigators aim to identify serological AHA biomarkers that are prognostic or predictive for postoperative morbidity, mortality and length of hospitalisation. Data collection Data on mortality was obtained using the Danish Civil Registration System(30). This register is maintained by the Danish government and assigns a unique personal identification number to all Danish citizens. It contains data on address, immigration emigration, gender, date of birth and exact day of death. It is updated within days of any change in information. Other data were collected in the medical records of patients. Complications were defined using the Clavien-Dindo Classification for Surgical Complications(31). Outcome measures Primary outcomes are short and long-term mortality (30 days and 180 days respectively) and major complications during index hospitalization (Clavien-Dindo >2). Secondary outcomes are length of hospitalisation, length of intensive care admission as well as perioperative need for inotropic or vasopressor support and high volume fluid resuscitation. Description of biological material 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. Limitations of the study Data collection during clinical work including blood samples requires resources and is susceptible to selection and information bias. It is possible that resources for collecting blood samples correctly where reduced for the most unstable patients at the time of induction of anaesthesia. Patients who were considered too frail to undergo surgery, where a palliative or conservative approach was chosen, were not included in this study. Postoperatively, patients in the AHA-cohort were assigned to postoperative intensive monitoring in the post-operative care unit if they had American Society of Anaesthesiologist physical performance score(34) above two. This stratification is susceptible to information-bias because of inter-observer variation(35). The data is collected in a single medical facility with and optimized care protocol for AHA and can therefore not uncritically be applied to other populations. Economical support and budget: The clinical study as well as establishment of the biobank has been supported by a grant from the Capital Region of Denmark (Region H). The cost of biochemical analysis will be covered by the Department of Clinical Biochemistry, Hvidovre Hospital. Other expenses will be covered by the AHA research group, Department of Anaesthesiology and Intensive Care and Department of Surgical Gastroenterology, Hvidovre Hospital. Publication of results: Results from the studies will be published in medical journals indexed in the PubMed/EMBASE database.


Recruitment information / eligibility

Status Completed
Enrollment 600
Est. completion date May 1, 2022
Est. primary completion date May 1, 2022
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Denmark Hvidovre University hospital Hvidovre Capital Region

Sponsors (2)

Lead Sponsor Collaborator
University of Copenhagen Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (32)

Al-Temimi MH, Griffee M, Enniss TM, Preston R, Vargo D, Overton S, Kimball E, Barton R, Nirula R. When is death inevitable after emergency laparotomy? Analysis of the American College of Surgeons National Surgical Quality Improvement Program database. J Am Coll Surg. 2012 Oct;215(4):503-11. doi: 10.1016/j.jamcollsurg.2012.06.004. Epub 2012 Jul 11. — View Citation

Benz F, Roy S, Trautwein C, Roderburg C, Luedde T. Circulating MicroRNAs as Biomarkers for Sepsis. Int J Mol Sci. 2016 Jan 9;17(1). pii: E78. doi: 10.3390/ijms17010078. Review. — View Citation

Botha S, Fourie CMT, Schutte R, Eugen-Olsen J, Pretorius R, Schutte AE. Soluble urokinase plasminogen activator receptor as a prognostic marker of all-cause and cardiovascular mortality in a black population. Int J Cardiol. 2015 Apr 1;184:631-636. doi: 10.1016/j.ijcard.2015.03.041. Epub 2015 Mar 4. — View Citation

Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. — View Citation

Donadello K, Scolletta S, Covajes C, Vincent JL. suPAR as a prognostic biomarker in sepsis. BMC Med. 2012 Jan 5;10:2. doi: 10.1186/1741-7015-10-2. Review. — View Citation

Donadello K, Scolletta S, Taccone FS, Covajes C, Santonocito C, Cortes DO, Grazulyte D, Gottin L, Vincent JL. Soluble urokinase-type plasminogen activator receptor as a prognostic biomarker in critically ill patients. J Crit Care. 2014 Feb;29(1):144-9. doi: 10.1016/j.jcrc.2013.08.005. Epub 2013 Oct 9. — View Citation

Gallo V, Egger M, McCormack V, Farmer PB, Ioannidis JP, Kirsch-Volders M, Matullo G, Phillips DH, Schoket B, Stromberg U, Vermeulen R, Wild C, Porta M, Vineis P; STROBE Statement. STrengthening the Reporting of OBservational studies in Epidemiology--Molecular Epidemiology (STROBE-ME): an extension of the STROBE Statement. PLoS Med. 2011 Oct;8(10):e1001117. doi: 10.1371/journal.pmed.1001117. Epub 2011 Oct 25. — View Citation

Ghaferi AA, Dimick JB. Importance of teamwork, communication and culture on failure-to-rescue in the elderly. Br J Surg. 2016 Jan;103(2):e47-51. doi: 10.1002/bjs.10031. Epub 2015 Nov 30. Review. — View Citation

Hobson SA, Sutton CD, Garcea G, Thomas WM. Prospective comparison of POSSUM and P-POSSUM with clinical assessment of mortality following emergency surgery. Acta Anaesthesiol Scand. 2007 Jan;51(1):94-100. Epub 2006 Nov 1. — View Citation

Hodges GW, Bang CN, Wachtell K, Eugen-Olsen J, Jeppesen JL. suPAR: A New Biomarker for Cardiovascular Disease? Can J Cardiol. 2015 Oct;31(10):1293-302. doi: 10.1016/j.cjca.2015.03.023. Epub 2015 Mar 25. Review. — View Citation

Jeppesen MH, Tolstrup MB, Kehlet Watt S, Gögenur I. Risk factors affecting morbidity and mortality following emergency laparotomy for small bowel obstruction: A retrospective cohort study. Int J Surg. 2016 Apr;28:63-8. doi: 10.1016/j.ijsu.2016.02.059. Epub 2016 Feb 18. — View Citation

Jhanji S, Thomas B, Ely A, Watson D, Hinds CJ, Pearse RM. Mortality and utilisation of critical care resources amongst high-risk surgical patients in a large NHS trust. Anaesthesia. 2008 Jul;63(7):695-700. doi: 10.1111/j.1365-2044.2008.05560.x. Epub 2008 May 16. — View Citation

Johansson PI, Stensballe J, Rasmussen LS, Ostrowski SR. A high admission syndecan-1 level, a marker of endothelial glycocalyx degradation, is associated with inflammation, protein C depletion, fibrinolysis, and increased mortality in trauma patients. Ann Surg. 2011 Aug;254(2):194-200. doi: 10.1097/SLA.0b013e318226113d. — View Citation

John J, Woodward DB, Wang Y, Yan SB, Fisher D, Kinasewitz GT, Heiselman D. Troponin-I as a prognosticator of mortality in severe sepsis patients. J Crit Care. 2010 Jun;25(2):270-5. doi: 10.1016/j.jcrc.2009.12.001. Epub 2010 Feb 10. — View Citation

Johnston MJ, Arora S, King D, Bouras G, Almoudaris AM, Davis R, Darzi A. A systematic review to identify the factors that affect failure to rescue and escalation of care in surgery. Surgery. 2015 Apr;157(4):752-63. doi: 10.1016/j.surg.2014.10.017. Review. — View Citation

Lahiri R, Derwa Y, Bashir Z, Giles E, Torrance HD, Owen HC, O'Dwyer MJ, O'Brien A, Stagg AJ, Bhattacharya S, Foster GR, Alazawi W. Systemic Inflammatory Response Syndrome After Major Abdominal Surgery Predicted by Early Upregulation of TLR4 and TLR5. Ann Surg. 2016 May;263(5):1028-37. doi: 10.1097/SLA.0000000000001248. — View Citation

Landesberg G, Jaffe AS, Gilon D, Levin PD, Goodman S, Abu-Baih A, Beeri R, Weissman C, Sprung CL, Landesberg A. Troponin elevation in severe sepsis and septic shock: the role of left ventricular diastolic dysfunction and right ventricular dilatation*. Crit Care Med. 2014 Apr;42(4):790-800. doi: 10.1097/CCM.0000000000000107. — View Citation

Liu X, Shen Y, Li Z, Fei A, Wang H, Ge Q, Pan S. Prognostic significance of APACHE II score and plasma suPAR in Chinese patients with sepsis: a prospective observational study. BMC Anesthesiol. 2016 Jul 29;16(1):46. doi: 10.1186/s12871-016-0212-3. — View Citation

Nemeth E, Rivera S, Gabayan V, Keller C, Taudorf S, Pedersen BK, Ganz T. IL-6 mediates hypoferremia of inflammation by inducing the synthesis of the iron regulatory hormone hepcidin. J Clin Invest. 2004 May;113(9):1271-6. — View Citation

Oliver CM, Walker E, Giannaris S, Grocott MP, Moonesinghe SR. Risk assessment tools validated for patients undergoing emergency laparotomy: a systematic review. Br J Anaesth. 2015 Dec;115(6):849-60. doi: 10.1093/bja/aev350. Epub 2015 Nov 3. Review. — View Citation

Pearse RM, Moreno RP, Bauer P, Pelosi P, Metnitz P, Spies C, Vallet B, Vincent JL, Hoeft A, Rhodes A; European Surgical Outcomes Study (EuSOS) group for the Trials groups of the European Society of Intensive Care Medicine and the European Society of Anaesthesiology. Mortality after surgery in Europe: a 7 day cohort study. Lancet. 2012 Sep 22;380(9847):1059-65. doi: 10.1016/S0140-6736(12)61148-9. — View Citation

Pedersen CB. The Danish Civil Registration System. Scand J Public Health. 2011 Jul;39(7 Suppl):22-5. doi: 10.1177/1403494810387965. — View Citation

Sandø A, Schultz M, Eugen-Olsen J, Rasmussen LS, Køber L, Kjøller E, Jensen BN, Ravn L, Lange T, Iversen K. Introduction of a prognostic biomarker to strengthen risk stratification of acutely admitted patients: rationale and design of the TRIAGE III cluster randomized interventional trial. Scand J Trauma Resusc Emerg Med. 2016 Aug 5;24:100. doi: 10.1186/s13049-016-0290-8. — View Citation

Sandquist M, Wong HR. Biomarkers of sepsis and their potential value in diagnosis, prognosis and treatment. Expert Rev Clin Immunol. 2014 Oct;10(10):1349-56. doi: 10.1586/1744666X.2014.949675. Epub 2014 Aug 21. Review. — View Citation

Sankar A, Johnson SR, Beattie WS, Tait G, Wijeysundera DN. Reliability of the American Society of Anesthesiologists physical status scale in clinical practice. Br J Anaesth. 2014 Sep;113(3):424-32. doi: 10.1093/bja/aeu100. Epub 2014 Apr 11. — View Citation

Saunders DI, Murray D, Pichel AC, Varley S, Peden CJ; UK Emergency Laparotomy Network. Variations in mortality after emergency laparotomy: the first report of the UK Emergency Laparotomy Network. Br J Anaesth. 2012 Sep;109(3):368-75. Epub 2012 Jun 22. — View Citation

Sheyin O, Davies O, Duan W, Perez X. The prognostic significance of troponin elevation in patients with sepsis: a meta-analysis. Heart Lung. 2015 Jan-Feb;44(1):75-81. doi: 10.1016/j.hrtlng.2014.10.002. Epub 2014 Nov 18. Review. — View Citation

Stoneham M, Murray D, Foss N. Emergency surgery: the big three--abdominal aortic aneurysm, laparotomy and hip fracture. Anaesthesia. 2014 Jan;69 Suppl 1:70-80. doi: 10.1111/anae.12492. Review. — View Citation

Symons NR, Moorthy K, Almoudaris AM, Bottle A, Aylin P, Vincent CA, Faiz OD. Mortality in high-risk emergency general surgical admissions. Br J Surg. 2013 Sep;100(10):1318-25. doi: 10.1002/bjs.9208. Epub 2013 Jul 17. — View Citation

Tolstrup MB, Watt SK, Gögenur I. Morbidity and mortality rates after emergency abdominal surgery: an analysis of 4346 patients scheduled for emergency laparotomy or laparoscopy. Langenbecks Arch Surg. 2017 Jun;402(4):615-623. doi: 10.1007/s00423-016-1493-1. Epub 2016 Aug 9. — View Citation

Vester-Andersen M, Lundstrøm LH, Møller MH, Waldau T, Rosenberg J, Møller AM; Danish Anaesthesia Database. Mortality and postoperative care pathways after emergency gastrointestinal surgery in 2904 patients: a population-based cohort study. Br J Anaesth. 2014 May;112(5):860-70. doi: 10.1093/bja/aet487. Epub 2014 Feb 10. — View Citation

Zeng M, Chang M, Zheng H, Li B, Chen Y, He W, Huang C. Clinical value of soluble urokinase-type plasminogen activator receptor in the diagnosis, prognosis, and therapeutic guidance of sepsis. Am J Emerg Med. 2016 Mar;34(3):375-80. doi: 10.1016/j.ajem.2015.11.004. Epub 2015 Nov 9. — View Citation

* Note: There are 32 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary No of patients died within 30 days postoperatively 30 day mortality after surgery 30 days
Primary No of patients died within 180 days postoperatively 180-day mortality after surgery 180 days
Primary No of patients with major postoperative complications within 30 days afer surgery Clavien Dindo grade more than 3a 30 days
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