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Surgical Stress Markers for Postoperative Complications: a Prospective Study

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ClinicalTrials.gov Identifier: NCT02356484
Recruitment Status : Completed
First Posted : February 5, 2015
Last Update Posted : December 30, 2015
Sponsor:
Information provided by (Responsible Party):
Nicolas DEMARTINES, University of Lausanne Hospitals

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.

Condition or disease
Operative Procedures, Complications

Study Type : Observational
Actual Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Predictive Value of Surgical Stress Markers for Postoperative Complications: a Prospective Study
Study Start Date : February 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: After Surgery

Group/Cohort
CRP group
Procalcitonin group
Albumine group
Lactate group



Primary Outcome Measures :
  1. Predictive value of postoperative albumin decrease in terms of surgical stress and postoperative complications [ Time Frame: Thirty days after the operation ]

Secondary Outcome Measures :
  1. Predictive value of postoperative CRP increase in terms of surgical stress and postoperative complications [ Time Frame: Thirty days after the operation ]
  2. Predictive value of postoperative procalcitonin increase in terms of surgical stress and postoperative complications [ Time Frame: Thirty days after the operation ]
  3. Predictive value of postoperative lactate increase in terms of surgical stress and postoperative complications [ Time Frame: Thirty days after the operation ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients undergoing major surgery (esophagus, gastric, liver, pancreas, endocrine, retroperitoneal, or colorectal surgery)
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

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): NCT02356484


Locations
Switzerland
University of Lausanne Hospital
Lausanne, Vaud, Switzerland
Sponsors and Collaborators
University of Lausanne Hospitals
Investigators
Principal Investigator: Martin Hübner, MD University of Lausanne Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nicolas DEMARTINES, Professor, University of Lausanne Hospitals
ClinicalTrials.gov Identifier: NCT02356484     History of Changes
Other Study ID Numbers: 471/14
First Posted: February 5, 2015    Key Record Dates
Last Update Posted: December 30, 2015
Last Verified: December 2015

Additional relevant MeSH terms:
Postoperative Complications
Pathologic Processes