Pathophysiology of Perioperative Fluid Management in Emergency Laparotomy

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

Pathophysiology of perioperative fluid management in patients undergoing emergency laparotomy.

Study Overview

• Status: Completed
• Conditions: Anastomotic Leak; Fluid Overload; Intestinal Obstruction; Pathophysiology; Intestinal Perforation

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 73

Contacts and Locations

Study Locations

• Denmark
  • Hvidovre, Denmark
    • Copenhagen University Hospital Hvidovre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adults (18 years or over) undergoing emergency high-risk abdominal surgery on suspicion of intestinal perforation (incl. ulcer), obstruction, anastomotic leak.

Description

Inclusion Criteria:

1. Adults (18 years or over) undergoing emergency high-risk abdominal surgery for following abdominal pathology:

   1. Perforated small intestine
   2. Perforated large intestine
   3. Perforated ulcer
   4. Intestinal obstruction
   5. Anastomotic leakage following elective surgery
2. Provided verbal and written informed consent
3. Must speak and understand the Danish language

Exclusion Criteria:

1. 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.
2. Primary surgery for intestinal ischemia, abdominal bleed
3. Emergency re-operations after elective surgery owing to intraabdominal bleeding, paralytic/obstructive ileus, intestinal ischemia
4. 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.
5. Traumas, gynecological, urogenital and other vascular pathology, pregnant patients.
6. Dementia and/or cognitive dysfunction (diagnosed).

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Perforation; Patients undergoing primary emergency laparotomy/laparoscopy due to suspicion of intestinal perforation or ( small intestine, large intestine), perforated ventricular or duodenal ulcer
Obstruction; Patients undergoing primary emergency laparotomy/laparoscopy due to suspicion of intestinal obstruction
Anasomotic leak; Patients undergoing primary emergency laparotomy/laparoscopy due to suspicion of anastomotic leak following elective surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The fluid distribution, during the early perioperative period (≤ 5 days), in patients with intestinal perforation versus intestinal obstruction versus postoperative complications with peritonitis.	Intra vs. extra vascular. Stroke volume assessment, Bioimpedance measurements	perioperative period

Secondary Outcome Measures

Outcome Measure	Time Frame
Impact of fluid distribution/fluid overload on preload dependency.	Preoperatively, 6 hours postoperatively and on first, third and fifth postoperative day
Impact of fluid distribution/fluid overload on peripheral perfusion.	Preoperatively, 6 hours postoperatively and on first, third and fifth postoperative day
Correlation between fluid balance just prior to surgery and intraoperative need for vasopressor/inotropes administration.	Preoperatively, 6 hours postoperatively and on first, third and fifth postoperative day
Evaluate the relationship between fluid overload and mortality rate in patients undergoing emergency laparotomy.	Preoperatively, 6 hours postoperatively and on first, third and fifth postoperative day
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.	Preoperatively, 6 hours postoperatively and on first, third and fifth postoperative day

Collaborators and Investigators

• Sponsor: Copenhagen University Hospital, Hvidovre
• Investigators: Study Chair: Nicolai Bang Foss, MD, DMSc, Department of Anesthesiology, Copenhagen University Hospital Hvidovre, Denmark

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 23, 2019
• Primary Completion (ACTUAL): March 2, 2021
• Study Completion (ACTUAL): May 1, 2021

Study Registration Dates

• First Submitted: May 23, 2019
• First Submitted That Met QC Criteria: June 23, 2019
• First Posted (ACTUAL): June 25, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 4, 2022
• Last Update Submitted That Met QC Criteria: September 30, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: pathophysiology; fluid overload; ileus; emergency laparotomy; intestinal perforation; perforated ulcer; perioperative fluid management
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Postoperative Complications; Disease Attributes; Gastrointestinal Diseases; Intestinal Diseases; Emergencies; Anastomotic Leak; Intestinal Obstruction; Intestinal Perforation
• Other Study ID Numbers: H-19010653

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No