Can Biomarkers Aid in the Prediction of Postoperative Pain and Circulatory Instability After Major Abdominal Surgery?
|ClinicalTrials.gov Identifier: NCT02563652|
Recruitment Status : Completed
First Posted : September 30, 2015
Last Update Posted : November 14, 2018
Patients undergoing major surgery are exposed to extensive damage of tissues, which induces widespread activation of the inflammatory system, called 'systemic inflammatory response syndrome' (SIRS).This activation of the inflammatory system may induce instability of the heart and respiration in the postoperative period. The degree of physiologic response to postoperative SIRS as well as the degree of postoperative pain differ between patients. Therefore, patients undergoing anesthesia and major surgery are treated in a 'post anesthesia care unit' (PACU) after end of surgery.Admittance to a PACU is expensive. The time patients need to stay in a PACU after major surgery has not been extensively studied, and more appropriate tools for prediction of length of stay are needed.
The main aim of this study is to assess whether clinical observations, inflammatory biomarkers or genetic markers may aid in the prediction of physiological instability and/or pain after major surgery. Such predictors would help clinicians planning the length of PACU-stays.
|Condition or disease|
|Systemic Inflammatory Response Syndrome|
|Study Type :||Observational|
|Actual Enrollment :||101 participants|
|Official Title:||Can Biomarkers Aid in the Prediction of Postoperative Pain and Circulatory Instability After Major Abdominal Surgery? A Prospective Observational Study|
|Actual Study Start Date :||September 2015|
|Actual Primary Completion Date :||September 2018|
|Actual Study Completion Date :||September 2018|
Major abdominal surgery
Patients undergoing major abdominal surgery (laparotomy). Surgical procedures considered for inclusion include, but are not restricted to, procedures such as gastrectomy, pancreatic surgery, liver resection, open prostatectomy, colonic surgery, radical cystectomy with ileal conduit, open nephrectomy and vascular abdominal aortic surgery.
- Time to established circulatory stability for > 2 hours [Time to event outcome] [ Time Frame: 48 hours ]Circulatory stability will be assessed by applying a multi-state statistical model, where any state changes are measured at an hourly basis. The model will include variables reflecting the circulatory state of the patient, including heart rate, systolic blood pressure (or MAP) and lactate, which will be assessed together with the measures needed to maintain them, such as the amount of fluid given (ml per hour) and the extent of vasopressor (i.e. norepinephrine). The main outcome variable will be the time needed to reach the state of 'stable without intervention for more than two hours. To be classified in this state, the systolic blood pressure must be > 100 mmHg, the heart rate between 40 and 110, the patient must be off vasopressor and has a fluid requirement of less than 250 ml/hour.
- Time to reaching a state of no or mild pain problem for > 2 hours [Time to event outcome] [ Time Frame: 48 hours ]This outcome will be reached when the patient has a numeric rating score (NRS) with respect to pain of < 4 and the opioid consumption is less than 5 mg morphine equivalents per hour.
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02563652
|University of Parma|
|St Olavs Hospital|
|Study Director:||Erik Solligård, phd md||St. Olavs Hospital|