Tissue Perfusion During Emergency Laparotomy

Correlation of Central and Peripheral Measures of Tissue Perfusion During Emergency Laparotomy - a Pilot Study

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.

Study Overview

• Status: Recruiting
• Conditions: Intestinal Obstruction; Emergency Laparotomy; Perforated Viscus

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.

• Study Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

Study Locations

• Denmark
  • Hvidovre, Denmark
    • Recruiting
    • Copenhagen University Hospital Hvidovre
    • Contact: Mirjana Cihoric, MD; Phone Number: +4522475828; Email: mirjana.cihoric.03@regionh.dk
    • Contact: Nicolai Bang Foss, MD, DMSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tissue perfusion and fluid status	changes in perfusion indices (delta values) after NA reduction, one fluid bolus, and subsequent restoration of blood pressure with Noradrenaline.	intraoperatively (during general anesthesia)
Tissue perfusion	Other endpoints of interest are the correlation between gut perfusion and indices of central and peripheral perfusion (urethral, cerebral, tissue).	intraoperatively (during general anesthesia)

Collaborators and Investigators

• Sponsor: Copenhagen University Hospital, Hvidovre

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 25, 2020
• Primary Completion (ANTICIPATED): November 30, 2022
• Study Completion (ANTICIPATED): November 30, 2022

Study Registration Dates

• First Submitted: May 21, 2020
• First Submitted That Met QC Criteria: May 21, 2020
• First Posted (ACTUAL): May 27, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 6, 2022
• Last Update Submitted That Met QC Criteria: March 27, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: emergency laparotomy; hemodynamic instability; tissue perfusion
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease Attributes; Gastrointestinal Diseases; Intestinal Diseases; Emergencies; Intestinal Obstruction
• Other Study ID Numbers: H-19069841

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No