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

Primary Purpose

Abdomen, Acute, Myocardial Injury, Acute Kidney Injury

Status
Active
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Chest CT without contrast enhancement and chest X-ray
Sponsored by
Nordsjaellands Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Abdomen, Acute

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Nordsjaellands Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All patients

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 18, 2020
Last Updated
August 18, 2023
Sponsor
Nordsjaellands Hospital
Collaborators
Bispebjerg Hospital, University of Southern Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT04681508
Brief Title
MINS, AKI and Pulmonary Pathology in Patients Undergoing Acute Abdominal Surgery
Official Title
Myocardial Injury After Non-cardiac Surgery (MINS), Acute Kidney Injury (AKI) and Pulmonary Pathology in Patients Undergoing Acute Abdominal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
July 31, 2025 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nordsjaellands Hospital
Collaborators
Bispebjerg Hospital, University of Southern Denmark

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdomen, Acute, Myocardial Injury, Acute Kidney Injury, Pulmonary Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
All patients
Arm Type
Experimental
Arm Description
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
Intervention Type
Diagnostic Test
Intervention Name(s)
Chest CT without contrast enhancement and chest X-ray
Intervention Description
Chest CT without contrast enhancement and chest X-ray as supplement to diagnostic abdominal CT
Primary Outcome Measure Information:
Title
Proportion of patients with myocardial injury af non-cardiac surgery
Description
Troponin-I above specified level and dynamic changes
Time Frame
30 days
Title
Mortality rate
Description
Postoperative mortality
Time Frame
30 days
Title
Mortality rate
Description
Postoperative mortality
Time Frame
90 days
Title
Mortality rate
Description
Postoperative mortality
Time Frame
1 year
Title
Acute kidney Injury
Description
According to KIDGO criteria
Time Frame
30 days
Title
Proportion of patients with pulmonary pathology
Description
Findings (including incidental) on a chest x-ray and chest CT scan without contrast enhancement
Time Frame
1 day
Title
Proportion of patients with pulmonary complications
Description
Postoperative complications
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claus A Bertelsen, PhD
Organizational Affiliation
Nordsjaellands Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Nordsjaellands Hospital
City
Hillerød
ZIP/Postal Code
3400
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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