Intestinal ObstructionNCT03997721
Pathophysiology of Perioperative Fluid Management in Emergency Laparotomy
An observational study of Intestinal Obstruction and Intestinal Perforation, run by Copenhagen University Hospital, Hvidovre at 1 site in Denmark.
Trial summary
Pathophysiology of perioperative fluid management in patients undergoing emergency laparotomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intestinal Obstruction, Intestinal Perforation, Anastomotic Leak
- How many people
- 73 participants
- Where
- 1 siteDenmark
- Study dates
- 23 May 2019to 1 May 2021
- How long will I take part?
- 90 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Adults (18 years or over) undergoing emergency high-risk abdominal surgery on suspicion of intestinal perforation (incl. ulcer), obstruction, anastomotic leak.
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pathophysiology of Perioperative Fluid Management in Patients Un-dergoing High Risk Emergency Laparotomy, a Prospective Descriptive Cohort Study
Pathophysiology of perioperative fluid management in patients undergoing emergency laparotomy.
Read the 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.
- Conditions
- Intestinal Obstruction, Intestinal Perforation, Anastomotic Leak, Fluid Overload, Pathophysiology
- Keywords
- emergency laparotomy, ileus, perforated ulcer, intestinal perforation, perioperative fluid management, pathophysiology, fluid overload
- Medical subject headings
- Intestinal Obstruction, Intestinal Perforation, Anastomotic Leak, Edema, Ileus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: perioperative period
Secondary outcomes (5)
Impact of fluid distribution/fluid overload on preload dependency.
Measured: Preoperatively, 6 hours postoperatively and on first, third and fifth postoperative day
Impact of fluid distribution/fluid overload on peripheral perfusion.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Preoperatively, 6 hours postoperatively and on first, third and fifth postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2019
- Study start23 May 2019
- Primary completion2 Mar 2021
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intestinal ObstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 73 participants (actual)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Hvidovre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mirjana Cihoric, Copenhagen University Hospital, Hvidovre
- Investigators
- Nicolai Bang Foss, MD, DMSc, Study chair, Department of Anesthesiology, Copenhagen University Hospital Hvidovre, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03997721
- Sponsor's protocol ID
- H-19010653
- Status last verified
- Sep 2022
- First submitted
- 23 May 2019
- Last updated
- 4 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36647120
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathophysiology of Perioperative Fluid Management in Patients Un-dergoing High Risk Emergency Laparotomy, a Prospective Descriptive Cohort Study
- ClinicalTrials.gov ID
- NCT03997721
- Acronym / sponsor ID
- H-19010653
- Conditions
- Intestinal Obstruction, Intestinal Perforation, Anastomotic Leak, Fluid Overload, Pathophysiology
- Keywords
- emergency laparotomy, ileus, perforated ulcer, intestinal perforation, perioperative fluid management, pathophysiology, fluid overload
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, HvidovreUniversity, hospital or other
- Study start
- 23 May 2019 (actual)
- Primary completion
- 2 Mar 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 25 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pathophysiology of perioperative fluid management in patients undergoing emergency laparotomy.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 90 Days
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adults (18 years or over) undergoing emergency high-risk abdominal surgery on suspicion of intestinal perforation (incl. ulcer), obstruction, anastomotic leak.
Key inclusion criteria (8 listed)
- Adults (18 years or over) undergoing emergency high-risk abdominal surgery for following abdominal pathology:
- Provided verbal and written informed consent
- Must speak and understand the Danish language
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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 vs. extra vascular. Stroke volume assessment, Bioimpedance measurements
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2022.
- Derived from this study: PubMed 36647120Cihoric 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolai Bang Foss, MD, DMSc study chair
Department of Anesthesiology, Copenhagen University Hospital Hvidovre, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intestinal Obstruction and Intestinal Perforation, run by Copenhagen University Hospital, Hvidovre at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03997721, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2022.