Clinical trial NCT03997721: Pathophysiology of Perioperative Fluid Management in Emergency Laparotomy
Official title: Pathophysiology of Perioperative Fluid Management in Patients Un-dergoing High Risk Emergency Laparotomy, a Prospective Descriptive Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intestinal Obstruction
Intestinal Perforation
Anastomotic Leak
Fluid Overload
Pathophysiology
Keywords: emergency laparotomy
ileus
perforated ulcer
intestinal perforation
perioperative fluid management
pathophysiology
fluid overload
Lead sponsor: Copenhagen University Hospital, Hvidovre
Sponsor class: OTHER
First posted: 2019-06-25
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: Pathophysiology of perioperative fluid management in patients undergoing emergency laparotomy.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: The fluid distribution, during the early perioperative period (≤ 5 days), in patients with intestinal perforation versus intestinal obstruction versus postoperative complications with peritonitis.
timeFrame: perioperative period
Secondary outcomes:
measure: Impact of fluid distribution/fluid overload on preload dependency.
timeFrame: Preoperatively, 6 hours postoperatively and on first, third and fifth postoperative day
measure: Impact of fluid distribution/fluid overload on peripheral perfusion.
timeFrame: Preoperatively, 6 hours postoperatively and on first, third and fifth postoperative day
measure: Correlation between fluid balance just prior to surgery and intraoperative need for vasopressor/inotropes administration.
timeFrame: Preoperatively, 6 hours postoperatively and on first, third and fifth postoperative day
measure: Evaluate the relationship between fluid overload and mortality rate in patients undergoing emergency laparotomy.
timeFrame: Preoperatively, 6 hours postoperatively and on first, third and fifth postoperative day
measure: 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.
timeFrame: Preoperatively, 6 hours postoperatively and on first, third and fifth postoperative day
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Copenhagen University Hospital Hvidovre
Study officials:
affiliation: Department of Anesthesiology, Copenhagen University Hospital Hvidovre, Denmark
name: Nicolai Bang Foss, MD, DMSc
role: STUDY_CHAIR
References: