MINS, AKI and Pulmonary Pathology in Patients Undergoing Acute Abdominal Surgery

Myocardial Injury After Non-cardiac Surgery (MINS), Acute Kidney Injury (AKI) and Pulmonary Pathology in Patients Undergoing Acute Abdominal Surgery

Explorative study to investigate potential predictors of myocardial injury, acute kidney injury and pulmonary disorder after acute high-risk abdominal surgery.

Study Overview

• Status: Active, not recruiting
• Conditions: Myocardial Injury; Acute Kidney Injury; Pulmonary Disease; Abdomen, Acute
• Intervention / Treatment: Diagnostic test: Chest CT without contrast enhancement and chest X-ray

Detailed Description

The main issues are:

• To investigate if coronary calcification predisposes the development of myocardial injury and causes an increased mortality rate.
• To evaluate the predictive value of NT-pro-BNP in relation to the development of MINS and the mortality rate.
• To evaluate the predictive value of different biomarkers of AKI in relation to which patients develop AKI.
• To examine the proteins, exosomes and single cell RNA during acute kidney injury in order to describe the molecular processes in the kidney during AKI.
• To examine whether a chest CT scan without contrast enhancement will change treatment decisions in the acute gastrointestinal patient compared with a chest x-ray.

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Hillerød, Denmark, 3400
    • Nordsjaellands Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults (≥18 years).
• Patients included in the AHA regimen undergoing CT on suspicion acute high-risk abdominal disorder e.g.g bowel obstruction GI perforation or ischemia, and need of emergency abdominal surgery, either laparoscopic surgery or laparotomy.
• Able to speak Danish. In case Danish was not spoken an interpreter was used to obtain the informed consent.
• Able to give informed consent.

Exclusion Criteria:

• Patients who cannot give informed consent to participate in the study 15 minutes after receiving verbal information regarding the study.
• Known chronic kidney disease requiring dialysis at the time of admission (only exclusion criteria for the part of the study relating to AKI).
• Patients included in the AHA regimen, but conservative treatment is chosen (only exclusion criteria for the part of the study relating to MINS and AKI).
• Patients not resident in Denmark.
• Patients not able to give informed consent.
• Patient not able to speak Danish and not enough time to obtain an interpreter.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: All patients; All patients undergo chest CT without contrast enhancement and chest X-ray. Blood and urine sampling from patients subsequently undergoing emergency laparoscopy or laparotomy. Otherwise standard care	Diagnostic test: Chest CT without contrast enhancement and chest X-ray; Chest CT without contrast enhancement and chest X-ray as supplement to diagnostic abdominal CT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with myocardial injury af non-cardiac surgery	Troponin-I above specified level and dynamic changes	30 days
Mortality rate	Postoperative mortality	30 days
Mortality rate	Postoperative mortality	90 days
Mortality rate	Postoperative mortality	1 year
Acute kidney Injury	According to KIDGO criteria	30 days
Proportion of patients with pulmonary pathology	Findings (including incidental) on a chest x-ray and chest CT scan without contrast enhancement	1 day
Proportion of patients with pulmonary complications	Postoperative complications	30 days

Collaborators and Investigators

• Sponsor: Nordsjaellands Hospital
• Collaborators: Bispebjerg Hospital; University of Southern Denmark
• Investigators: Study Chair: Claus A Bertelsen, PhD, Nordsjaellands Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Estimated): July 31, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: December 18, 2020
• First Submitted That Met QC Criteria: December 18, 2020
• First Posted (Actual): December 23, 2020

Study Record Updates

• Last Update Posted (Actual): August 21, 2023
• Last Update Submitted That Met QC Criteria: August 18, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms, Digestive; Renal Insufficiency; Abdominal Pain; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Wounds and Injuries; Acute Kidney Injury; Abdomen, Acute
• Other Study ID Numbers: AHA (Other Identifier: American Heart Association)

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