Surgical Stress Markers for Postoperative Complications: a Prospective Study

NCT ID: NCT02356484

Last Updated: 2020-08-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2015-12-31

Brief Summary

The aim of this study is to evaluate the predictive value of albumine, C-reactive protein (CRP), procalcitonin, and lactates in terms of surgical stress and postoperative complications. These biomarkers will be measured from the day before surgery until postoperative day four in patients undergoing major surgery. Major surgery was defined as esophagus, gastric, liver, pancreas, endocrine, retroperitoneal, or colorectal procedures including an organ resection for benign or malignant disease and lasting more than 2 hours.

Detailed Description

This prospective study was conducted at the Department for Visceral Surgery at the University Hospital of Lausanne Switzerland (CHUV) between February and December 2015 (NCT02356484). The study was approved by the Institutional Review Board (No. 367/15), and all patients provided written consent prior to surgery. Inclusion criteria were age >18 years, and elective major abdominal surgery-defined as an operative procedure with anticipated duration ≥2 hours.17 Perioperative care closely adhered to recently published enhanced recovery guidelines (http://erassociety.org.loopiadns.com/guidelines/list-of-guidelines). Standardised fluid administration was followed by advanced haemodynamic monitoring to avoid intraoperative fluid overload. According to the clinical care pathway, intravenous fluid was typically discontinued the morning after surgery.

Biological markers Serum levels of albumin, CRP, PCT and lactate (LCT) were perioperatively measured in a fasting state, Following standardised institutional guidelines. Blood samples were drawn the day before surgery, the day of surgery (4-6 hours after the end of the operation) and on the first, second and third postoperative day. As Baseline values tend to show large variations especially for albumin,4 10 we considered that a dynamic value (difference between two time-points) might be more informative than a snapshot value. Several values based on preoperative and postoperative concentrations were thus calculated for each marker (ie, Δ Max: maximal difference between the preoperative and postoperative values; Δ POD 0: difference of concentration on POD -1 and POD 0; Δ POD 1: difference of concentration on POD-1 and POD 1).

Conditions

Operative Procedures, Complications

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Major abdominal surgery cohort

In this surgical cohort, 4 inflammatory markers were measured: albumin, procalcitonin, CRP and lactate levels

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Patients over 18 years old
• Patients undergoing esophagus, gastric, liver, pancreas, endocrine, retroperitoneal, or colorectal surgery
• Operation time more than 2 hours
• Operation including an organ resection for benign or malignant disease

Exclusion Criteria

• Immunosuppressive therapy
• Cognitive impairment or language comprehension problems
• Absence of the consent form prior to first blood sample

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Lausanne Hospitals

OTHER

Sponsor Role: lead

Responsible Party

Nicolas DEMARTINES

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Martin Hübner, MD

Role: PRINCIPAL_INVESTIGATOR

University of Lausanne Hospitals

Locations

University of Lausanne Hospital

Lausanne, Canton of Vaud, Switzerland

Countries

Switzerland

References

Labgaa I, Joliat GR, Kefleyesus A, Mantziari S, Schafer M, Demartines N, Hubner M. Is postoperative decrease of serum albumin an early predictor of complications after major abdominal surgery? A prospective cohort study in a European centre. BMJ Open. 2017 Apr 8;7(4):e013966. doi: 10.1136/bmjopen-2016-013966.

Reference Type: DERIVED

PMID: 28391235 (View on PubMed)

Other Identifiers

471/14

Identifier Type: -

Identifier Source: org_study_id