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Clinical Trials/NCT04681508
NCT04681508
Active, not recruiting
Not Applicable

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

Nordsjaellands Hospital1 site in 1 country600 target enrollmentMarch 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Abdomen, Acute
Sponsor
Nordsjaellands Hospital
Enrollment
600
Locations
1
Primary Endpoint
Acute kidney Injury
Status
Active, not recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2021
End Date
December 31, 2026
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Nordsjaellands Hospital
Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Acute kidney Injury

Time Frame: 30 days

According to KIDGO criteria

Proportion of patients with myocardial injury af non-cardiac surgery

Time Frame: 30 days

Troponin-I above specified level and dynamic changes

Mortality rate

Time Frame: 1 year

Postoperative mortality

Proportion of patients with pulmonary pathology

Time Frame: 1 day

Findings (including incidental) on a chest x-ray and chest CT scan without contrast enhancement

Proportion of patients with pulmonary complications

Time Frame: 30 days

Postoperative complications

Study Sites (1)

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