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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04681508
Other study ID # AHA
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date March 1, 2021
Est. completion date December 31, 2026

Study information

Verified date August 2023
Source Nordsjaellands Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 600
Est. completion date December 31, 2026
Est. primary completion date July 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Intervention

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

Locations

Country Name City State
Denmark Nordsjaellands Hospital Hillerød

Sponsors (3)

Lead Sponsor Collaborator
Nordsjaellands Hospital Bispebjerg Hospital, University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

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