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

Not Applicable

Active, not recruiting

• Conditions: Pulmonary Disease; Myocardial Injury; Acute Kidney Injury; Abdomen, Acute
• Interventions: Diagnostic Test: Chest CT without contrast enhancement and chest X-ray

• Registration Number: NCT04681508
• Lead Sponsor: Nordsjaellands Hospital

Brief Summary

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

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 Timeline

• Study First Submitted: 2020-12-18
• Study First Submitted QC: 2020-12-18
• Study First Posted: 2020-12-23
• Study Start: 2021-03-01
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-18
• Last Update Posted: 2023-08-21
• Primary Completion: 2025-07-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 600

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All patients	Chest CT without contrast enhancement and chest X-ray	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

Primary Outcome Measures

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

Trial Locations

Locations (1)

Nordsjaellands Hospital; 🇩🇰 Hillerød, Denmark