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

NCT ID: NCT04681508

Last Updated: 2023-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2026-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Abdomen, Acute Myocardial Injury Acute Kidney Injury Pulmonary Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Chest CT without contrast enhancement and chest X-ray

Intervention Type DIAGNOSTIC_TEST

Chest CT without contrast enhancement and chest X-ray as supplement to diagnostic abdominal CT

Interventions

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Chest CT without contrast enhancement and chest X-ray

Chest CT without contrast enhancement and chest X-ray as supplement to diagnostic abdominal CT

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bispebjerg Hospital

OTHER

Sponsor Role collaborator

University of Southern Denmark

OTHER

Sponsor Role collaborator

Nordsjaellands Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Claus A Bertelsen, PhD

Role: STUDY_CHAIR

Nordsjaellands Hospital

Locations

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Nordsjaellands Hospital

Hillerød, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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AHA

Identifier Type: -

Identifier Source: org_study_id

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