Pathophysiology of Perioperative Fluid Management in Emergency Laparotomy
NCT ID: NCT03997721
Last Updated: 2022-10-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
73 participants
OBSERVATIONAL
2019-05-23
2021-05-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Perioperative Metabolic and Hormonal Aspects in Major Emergency Surgery
NCT03482830
Standardized Perioperative Management of Patients Operated With Acute Abdominal Surgery in a High-risk Emergency Setting
NCT03549624
Meta-Analysis on Damage Control Surgery in Patients With Non-Traumatic Abdominal Emergencies
NCT04448912
Damage Control Laparotomy
NCT02706041
Preserving or Resecting the Normal Appendix in Patients Undergoing Laparoscopy Surgery for Suspected Appendicitis
NCT06917612
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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).
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Copenhagen University Hospital, Hvidovre
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Mirjana Cihoric
MD, Research fellow
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Nicolai Bang Foss, MD, DMSc
Role: STUDY_CHAIR
Department of Anesthesiology, Copenhagen University Hospital Hvidovre, Denmark
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Copenhagen University Hospital Hvidovre
Hvidovre, , Denmark
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
H-19010653
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.