An observational study in Intestinal Obstruction, Intestinal Perforation and Anastomotic Leak, sponsored by Copenhagen University Hospital, Hvidovre. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-10-04.
Sponsored by Copenhagen University Hospital, Hvidovre · Observational
Pathophysiology of perioperative fluid management in patients undergoing emergency laparotomy.
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.
104 studies on the registry are indexed under Intestinal Obstruction; 15 are open to participants now.
This study's enrollment of 73 is below the median of 107 across 40 observational studies indexed under Intestinal Obstruction.
Browse Intestinal Obstruction studies →Copenhagen University Hospital, Hvidovre is the lead sponsor of 79 studies on the registry; 19 are open to participants now.
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Adults (18 years or over) undergoing emergency high-risk abdominal surgery on suspicion of intestinal perforation (incl. ulcer), obstruction, anastomotic leak.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Adults (18 years or over) undergoing emergency high-risk abdominal surgery for following abdominal pathology:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients undergoing primary emergency laparotomy/laparoscopy due to suspicion of intestinal perforation or ( small intestine, large intestine), perforated ventricular or duodenal ulcer
Patients undergoing primary emergency laparotomy/laparoscopy due to suspicion of intestinal obstruction
Patients undergoing primary emergency laparotomy/laparoscopy due to suspicion of anastomotic leak following elective surgery.
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
Time frame: perioperative period
Impact of fluid distribution/fluid overload on preload dependency.
Time frame: Preoperatively, 6 hours postoperatively and on first, third and fifth postoperative day
Impact of fluid distribution/fluid overload on peripheral perfusion.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Preoperatively, 6 hours postoperatively and on first, third and fifth postoperative day
Plan to share: No
No publications or documents are linked to this record.
Ran from May 2019 to primary completion in Mar 2021, 21 months.
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This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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Copenhagen University Hospital, Hvidovre