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Completed

NCT Number: NCT03997721

Pathophysiology of Perioperative Fluid Management in Emergency Laparotomy

Pathophysiology of perioperative fluid management in patients undergoing emergency laparotomy.

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Key information

About this study

In critically ill patients and patients undergoing major surgery, the combination of internal fluid shifts and fluid retention resulting in extravascular fluid accumulation and postoperative organ dysfunctions, complicates perioperative fluid management and influences patient outcome.

Changes in extravascular volume after surgery have been much debated, studies in major surgery suggest that extracellular volume expansion may correlate with intraoperative fluid administration, while other studies show the intravascular volume to be decreased after surgery.

Difficulty in obtaining accurate measurements of the fluid phases is recognized and despite years of research, perioperative extravascular volume changes have not been clarified in acute high-risk abdominal (AHA) surgery. It is essential to be able to identify and characterize the transition from necessary fluid resuscitation to harmful fluid volume accumulation, intra- as well as extravascular.

The present study seeks to investigate the perioperative fluid status and fluid shifts in patients undergoing AHA surgery, specifically focusing on intra- versus extra-vascular fluid status in patients with intestinal obstruction versus intestinal perforation.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults (18 years or over) undergoing emergency high-risk abdominal surgery for following abdominal pathology:
  • Perforated small intestine
  • Perforated large intestine
  • Perforated ulcer
  • Intestinal obstruction
  • Anastomotic leakage following elective surgery
  • Provided verbal and written informed consent
  • Must speak and understand the Danish language

Exclusion criteria

  • Appendectomies, cholecystectomies, negative diagnostic laparoscopies/laparotomies, herniotomies without bowel resections, sub-acute internal hernias after gastric bypass surgery, sub-acute surgery for inflammatory bowel diseases.
  • Primary surgery for intestinal ischemia, abdominal bleed
  • Emergency re-operations after elective surgery owing to intraabdominal bleeding, paralytic/obstructive ileus, intestinal ischemia
  • Reoperation owing to fascial separation with no other abdominal pathology identified and sub-acute colorectal cancer-surgery were excluded from the cohort. Sub-acute surgery was defined as surgery planned within 48 hours.
  • Traumas, gynecological, urogenital and other vascular pathology, pregnant patients.
  • Dementia and/or cognitive dysfunction (diagnosed).

Treatment and study plan

Primary outcomes

  1. The fluid distribution, during the early perioperative period (≤ 5 days), in patients with intestinal perforation versus intestinal obstruction versus postoperative complications with peritonitis.

    Time frame: perioperative period

    Intra vs. extra vascular. Stroke volume assessment, Bioimpedance measurements

Secondary outcomes

  1. Impact of fluid distribution/fluid overload on preload dependency.

    Time frame: Preoperatively, 6 hours postoperatively and on first, third and fifth postoperative day

  2. Impact of fluid distribution/fluid overload on peripheral perfusion.

    Time frame: Preoperatively, 6 hours postoperatively and on first, third and fifth postoperative day

  3. Correlation between fluid balance just prior to surgery and intraoperative need for vasopressor/inotropes administration.

    Time frame: Preoperatively, 6 hours postoperatively and on first, third and fifth postoperative day

  4. Evaluate the relationship between fluid overload and mortality rate in patients undergoing emergency laparotomy.

    Time frame: Preoperatively, 6 hours postoperatively and on first, third and fifth postoperative day

  5. Association between pre- to postoperative changes in volume status and perioperative fluid volume administration, in patients with intestinal perforation versus intestinal obstruction versus postoperative complications with peritonitis.

    Time frame: Preoperatively, 6 hours postoperatively and on first, third and fifth postoperative day

Sponsors and collaborators

Lead sponsor

Copenhagen University Hospital, Hvidovre

Other

Registry information

Official study title

Pathophysiology of Perioperative Fluid Management in Patients Un-dergoing High Risk Emergency Laparotomy, a Prospective Descriptive Cohort Study

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jun 25, 2019
Registry last updated
Oct 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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