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Can Biomarkers Aid in the Prediction of Postoperative Pain and Circulatory Instability After Major Abdominal Surgery?

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ClinicalTrials.gov Identifier: NCT02563652
Recruitment Status : Completed
First Posted : September 30, 2015
Last Update Posted : November 14, 2018
Sponsor:
Collaborators:
University of Parma
Study in Multidisciplinary Pain Research Group, Italy
IRCCS Policlinico S. Matteo
Information provided by (Responsible Party):
St. Olavs Hospital

Brief Summary:

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

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Study Type : Observational
Actual Enrollment : 101 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Group/Cohort
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.



Primary Outcome Measures :
  1. 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.

  2. 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
Full blood, serum, plasma and urine will be stored in cryotubes at -81 degrees celcius for later analysis


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients eligible for major abdominal surgery in St Olavs Hospital, Trondheim, Norway
Criteria

Inclusion Criteria:

  • Patients undergoing major abdominal surgery (e.g. Whipple's operation, liver resection, abdominoperineal resection, vascular abdominal surgery etc.)
  • Scheduled for PACU stay first 24 hours

Exclusion Criteria:

  • Pregnancy
  • Jehovah's witness
  • Dementia

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): NCT02563652


Locations
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Italy
University of Parma
Parma, Italy
Norway
St Olavs Hospital
Trondheim, Norway
Sponsors and Collaborators
St. Olavs Hospital
University of Parma
Study in Multidisciplinary Pain Research Group, Italy
IRCCS Policlinico S. Matteo
Investigators
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Study Director: Erik Solligård, phd md St. Olavs Hospital
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Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT02563652    
Other Study ID Numbers: 2015/641
First Posted: September 30, 2015    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by St. Olavs Hospital:
Abdomen/surgery
Biological markers
Length of stay
Postoperative care
Anesthesia recovery period
Prognosis
Additional relevant MeSH terms:
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Pain, Postoperative
Systemic Inflammatory Response Syndrome
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Inflammation
Shock