Pathophysiology of Perioperative Fluid Management in Emergency Laparotomy

NCT ID: NCT03997721

Last Updated: 2022-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

73 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-23

Study Completion Date

2021-05-01

Brief Summary

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Pathophysiology of perioperative fluid management in patients undergoing emergency laparotomy.

Detailed Description

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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.

Conditions

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Intestinal Obstruction Intestinal Perforation Anastomotic Leak Fluid Overload Pathophysiology

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Perforation

Patients undergoing primary emergency laparotomy/laparoscopy due to suspicion of intestinal perforation or ( small intestine, large intestine), perforated ventricular or duodenal ulcer

No interventions assigned to this group

Obstruction

Patients undergoing primary emergency laparotomy/laparoscopy due to suspicion of intestinal obstruction

No interventions assigned to this group

Anasomotic leak

Patients undergoing primary emergency laparotomy/laparoscopy due to suspicion of anastomotic leak following elective surgery.

No interventions assigned to this group

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Copenhagen University Hospital, Hvidovre

OTHER

Sponsor Role lead

Responsible Party

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Mirjana Cihoric

MD, Research fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nicolai Bang Foss, MD, DMSc

Role: STUDY_CHAIR

Department of Anesthesiology, Copenhagen University Hospital Hvidovre, Denmark

Locations

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Copenhagen University Hospital Hvidovre

Hvidovre, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 36647120 (View on PubMed)

Other Identifiers

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H-19010653

Identifier Type: -

Identifier Source: org_study_id

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