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Pathophysiology of Perioperative Fluid Management in Emergency Laparotomy

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ClinicalTrials.gov Identifier: NCT03997721
Recruitment Status : Recruiting
First Posted : June 25, 2019
Last Update Posted : June 25, 2019
Sponsor:
Information provided by (Responsible Party):
Mirjana Cihoric, Copenhagen University Hospital, Hvidovre

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

Condition or disease
Intestinal Obstruction Intestinal Perforation Anastomotic Leak Fluid Overload Pathophysiology

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 90 Days
Official Title: Pathophysiology of Perioperative Fluid Management in Patients Un-dergoing High Risk Emergency Laparotomy, a Prospective Descriptive Cohort Study
Actual Study Start Date : May 23, 2019
Estimated Primary Completion Date : November 1, 2019
Estimated Study Completion Date : March 1, 2020

Group/Cohort
Perforation
Patients undergoing primary emergency laparotomy/laparoscopy due to suspicion of intestinal perforation or ( small intestine, large intestine), perforated ventricular or duodenal ulcer
Obstruction
Patients undergoing primary emergency laparotomy/laparoscopy due to suspicion of intestinal obstruction
Anasomotic leak
Patients undergoing primary emergency laparotomy/laparoscopy due to suspicion of anastomotic leak following elective surgery.



Primary Outcome Measures :
  1. The fluid distribution, during the early perioperative period (≤ 5 days), in patients with intestinal perforation versus intestinal obstruction versus postoperative complications with peritonitis. [ Time Frame: perioperative period ]
    Intra- versus extra-vascular fluid status


Secondary Outcome Measures :
  1. Impact of fluid distribution/fluid overload on preload dependency. [ Time Frame: Preoperatively, 6 hours postoperatively and on first, third and fifth postoperative day ]
  2. Impact of fluid distribution/fluid overload on peripheral perfusion. [ Time Frame: Preoperatively, 6 hours postoperatively and on first, third and fifth postoperative day ]
  3. 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 ]
  4. 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 ]
  5. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03997721


Contacts
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Contact: Mirjana Cihoric, MD +4522475828 mirjana.cihoric.03@regionh.dk
Contact: Nicolai Bang Foss, MD, DMSc nicolai.bang.foss@regionh.dk

Locations
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Denmark
Copenhagen University Hospital Hvidovre Recruiting
Hvidovre, Denmark
Contact: Mirjana Cihoric, MD    +4522475828    mirjana.cihoric.03@regionh.dk   
Contact: Nicolai Bang Foss, MD, DMSc         
Sponsors and Collaborators
Copenhagen University Hospital, Hvidovre
Investigators
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Study Chair: Nicolai Bang Foss, MD, DMSc Department of Anesthesiology, Copenhagen University Hospital Hvidovre, Denmark

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Responsible Party: Mirjana Cihoric, MD, Research fellow, Copenhagen University Hospital, Hvidovre
ClinicalTrials.gov Identifier: NCT03997721     History of Changes
Other Study ID Numbers: H-19010653
First Posted: June 25, 2019    Key Record Dates
Last Update Posted: June 25, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mirjana Cihoric, Copenhagen University Hospital, Hvidovre:
emergency laparotomy
ileus
perforated ulcer
intestinal perforation
perioperative fluid management
pathophysiology
fluid overload

Additional relevant MeSH terms:
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Emergencies
Pathologic Processes
Anastomotic Leak
Intestinal Obstruction
Intestinal Perforation
Disease Attributes
Postoperative Complications
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases