Tissue Perfusion During Emergency Laparotomy

NCT04403425 | Unknown

• 1 other identifier: H-19069841
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study is investigating the effect of intraoperative Noradrenaline on cardiac preload and stroke volume, after initial fluid resuscitation, in order to assess whether there is a masked preload responsiveness and ultimately whether the correction of this potential preload-responsiveness with fluid therapy will translate into increased tissue perfusion in emergency laparotomy.

Conditions

Emergency Laparotomy; Intestinal Obstruction; Perforated Viscus

Keywords

emergency laparotomy; tissue perfusion; hemodynamic instability

Outcome Measures

Primary Outcomes (1)

• Preload dependency

  the incidence of preload dependency defined as stroke volume increase of \>10% during fluid challenge after reduction of Noradrenaline.

  intraoperatively (during general anesthesia)

Secondary Outcomes (2)

• Tissue perfusion and fluid status

  intraoperatively (during general anesthesia)

• Tissue perfusion

  intraoperatively (during general anesthesia)

Study Arms (2)

Emergency laparotomy, obstruction

Patients undergoing emergency laparotomy for intestinal obstruction in need of intraoperative Noradrenaline infusion to maintain predefined normotension.

Emergency laparotomy, perforation

Patients undergoing emergency laparotomy for perforated ventricle or intestine in need of intraoperative Noradrenaline infusion to maintain predefined normotension.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will include patients undergoing emergency laparotomy on suspicion of abdominal pathology, in need of intraoperative Noradrenaline infusion to maintain predefined normotension.

You may qualify if:

• Adults (18 years or over) undergoing emergency laparotomy/laparoscopy for following abdominal pathology:
• Perforated viscus
• Intestinal obstruction
• Emergency re-operations after elective surgery owing to paralytic/obstructive ileus, anastomotic leakage
• Provided verbal and written informed consent
• Must speak and understand the Danish language
• Intraoperative indication for Norepinephrine infusion

You may not qualify if:

• 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.
• Reoperation owing to fascial separation with no other abdominal pathology identified and sub-acute colorectal cancer-surgery will be excluded from the cohort. Sub-acute surgery is defined as surgery planned within 48 hours.
• Intestinal Ischemia
• intraabdominal bleeding
• Traumas, gynecological, urogenital and other vascular pathology, pregnant patients.

Sponsors & Collaborators

• Copenhagen University Hospital, Hvidovre: lead

Study Sites (1)

Copenhagen University Hospital Hvidovre

Hvidovre, Denmark

RECRUITING

MeSH Terms

Conditions

Intestinal Obstruction

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Research fellow

Study Record Dates

• First Submitted: May 21, 2020
• First Posted: May 27, 2020
• Study Start: December 25, 2020
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: April 6, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)