Pathophysiology of Perioperative Fluid Management in Emergency Laparotomy

Study Overview
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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.

Official Title
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Pathophysiology of Perioperative Fluid Management in Patients Un-dergoing High Risk Emergency Laparotomy, a Prospective Descriptive Cohort Study

Conditions
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Intestinal Obstruction, Intestinal Perforation, Anastomotic Leak, Fluid Overload, Pathophysiology

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Perforation<br>Patients undergoing primary emergency laparotomy/laparoscopy due to suspicion of intestinal perforation or ( small intestine, large intestine), perforated ventricular or duodenal ulcer | |
| Obstruction<br>Patients undergoing primary emergency laparotomy/laparoscopy due to suspicion of intestinal obstruction | |
| Anasomotic leak<br>Patients undergoing primary emergency laparotomy/laparoscopy due to suspicion of anastomotic leak following elective surgery. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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emergency laparotomy, ileus, perforated ulcer, intestinal perforation, perioperative fluid management, pathophysiology, fluid overload