Tissue Perfusion During Emergency Laparotomy

NCT ID: NCT04403425

Last Updated: 2022-04-06

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-12-25
• Study Completion Date: 2022-11-30

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.

Detailed Description

Early detection and treatment of insufficient tissue perfusion and oxygenation is the main purpose of perioperative haemodynamic monitoring and management. Hypovolemia, septicaemia, and low flow states affecting central and peripheral perfusion are frequent in patients undergoing emergency laparotomy.

This study aims to assess the effects of Noradrenaline (NA) on cardiac preload, and tissue perfusion in patients undergoing emergency laparotomy, to investigate potential macro/microcirculatory uncoupling.

A single-centre, prospective interventional non-blinded single-arm study at the Department of Anaesthesiology and Intensive care Unit, Copenhagen University Hospital Hvidovre, Denmark. We will include patients undergoing emergency laparotomy. The study start is January 2021. After informed consent, patients will be included if they have an intraoperative need for Noradrenaline infusion >0.1 mcg/kg/min to maintain MAP ≥65 mmHg after resuscitation with a goal-directed fluid therapy algorithm. 20 patients will be included.

Intervention: At a steady state (MAP ≥65 mmHg) during the surgical procedure, we will reduce NA to investigate whether patients will be preload responsive while maintaining MAP > 50 mmHg and limiting stroke volume reduction to no more than 30%. After a subsequent fluid challenge, we will increase the dose of NA to re-establish a MAP ≥65 mmHg. In addition, peripheral and central perfusion indices, including gut perfusion, will be measured.

Conditions

Emergency Laparotomy; Intestinal Obstruction; Perforated Viscus

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Emergency laparotomy, obstruction

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

No interventions assigned to this group

Emergency laparotomy, perforation

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

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Adults (18 years or over) undergoing emergency laparotomy/laparoscopy for following abdominal pathology:

1. Perforated viscus

2. Intestinal obstruction

2. Emergency re-operations after elective surgery owing to paralytic/obstructive ileus, anastomotic leakage

3. Provided verbal and written informed consent

4. Must speak and understand the Danish language

5. Intraoperative indication for Norepinephrine infusion

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. 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.

3. Intestinal Ischemia

4. intraabdominal bleeding

5. Traumas, gynecological, urogenital and other vascular pathology, pregnant patients.

6. Dementia and/or cognitive dysfunction (diagnosed). If the patient is not awake, alert, and oriented, times three (to person, place, and time), this also qualifies as an exclusion criterion.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Copenhagen University Hospital, Hvidovre

OTHER

Sponsor Role: lead

Responsible Party

Mirjana Cihoric

MD, Research fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Copenhagen University Hospital Hvidovre

Hvidovre, , Denmark

Site Status: RECRUITING

Countries

Denmark

Facility Contacts

Mirjana Cihoric, MD

Role: primary

mirjana.cihoric.03@regionh.dk

+4522475828

Nicolai Bang Foss, MD, DMSc

Role: backup

Other Identifiers

H-19069841

Identifier Type: -

Identifier Source: org_study_id