Pathophysiology of Perioperative Fluid Management in Emergency Laparotomy

NCT03997721 | Completed

• 1 other identifier: H-19010653
• Study Type: observational
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

Pathophysiology of perioperative fluid management in patients undergoing emergency laparotomy.

Conditions

Intestinal Obstruction; Intestinal Perforation; Anastomotic Leak; Fluid Overload; Pathophysiology

Keywords

emergency laparotomy; ileus; perforated ulcer; intestinal perforation; perioperative fluid management; pathophysiology; fluid overload

Outcome Measures

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.

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

  perioperative period

Secondary Outcomes (5)

• 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

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Copenhagen University Hospital, Hvidovre: lead

Study Sites (1)

Copenhagen University Hospital Hvidovre

Hvidovre, Denmark

Location

Related Publications (1)

• Cihoric M, Kehlet H, Hojlund J, Lauritsen ML, Kanstrup K, Foss NB. Perioperative changes in fluid distribution and haemodynamics in acute high-risk abdominal surgery. Crit Care. 2023 Jan 16;27(1):20. doi: 10.1186/s13054-023-04309-9.

  PMID: 36647120 DERIVED

MeSH Terms

Conditions

Intestinal Obstruction; Intestinal Perforation; Anastomotic Leak; Edema; Ileus

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Nicolai Bang Foss, MD, DMSc

  Department of Anesthesiology, Copenhagen University Hospital Hvidovre, Denmark

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 90 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Research fellow

Study Record Dates

• First Submitted: May 23, 2019
• First Posted: June 25, 2019
• Study Start: May 23, 2019
• Primary Completion: March 2, 2021
• Study Completion: May 1, 2021
• Last Updated: October 4, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)