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the PRECious Trial: PREdiction of Complications

NCT02102217 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 525

Last updated 2020-11-06

No results posted yet for this study

Summary

20% of patients who undergo major abdominal surgery will have a major complication, which requires invasive treatment and is associated with increased mortality, morbidity, hospital stay and intensive care stay. A quality control algorithm after Major Abdominal Surgery (MAS) aimed at early identification of patients at risk of developing major complications can decrease associated morbidity and mortality. Literature studies show promising results for C-reactive protein as an early marker for postoperative complications, however clinical significance has yet to be determined. Here the investigators propose a randomized clinical trial in order to determine the effect of postoperative monitoring with standardized CRP measurements on postoperative morbidity and mortality, if CRP levels exceed 140 mg/L additional CT-scan imaging will be conducted.

Conditions

  • Postoperative Complications

Interventions

PROCEDURE

PRECious

Standardized measurement of serum CRP levels on postoperative day 3,4 and 5.

Sponsors & Collaborators

  • Amsterdam UMC, location VUmc

    lead OTHER

Principal Investigators

  • Jennifer Straatman, MD · VU Medisch Centrum

  • Donald van der Peet, MD, PhD · VU Medisch Centrum

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2020-05-31
Completion
2020-09-30

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02102217 on ClinicalTrials.gov