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Active, Not Recruiting

NCT Number: NCT04681508

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Abdomen, Acute Abdominal Pain Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Lung Diseases Male Urogenital Diseases Myocardial Injury Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Pulmonary Disease Renal Insufficiency Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Digestive Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nordsjaellands Hospital

Hillerød, 3400, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Chest CT without contrast enhancement and chest X-ray

Diagnostic Test

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

Primary outcomes

  1. Proportion of patients with myocardial injury af non-cardiac surgery

    Time frame: 30 days

    Troponin-I above specified level and dynamic changes

  2. Mortality rate

    Time frame: 30 days

    Postoperative mortality

  3. Mortality rate

    Time frame: 90 days

    Postoperative mortality

  4. Mortality rate

    Time frame: 1 year

    Postoperative mortality

  5. Acute kidney Injury

    Time frame: 30 days

    According to KIDGO criteria

  6. 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

  7. Proportion of patients with pulmonary complications

    Time frame: 30 days

    Postoperative complications

Sponsors and collaborators

Lead sponsor

Nordsjaellands Hospital

Other

Collaborators

  • Bispebjerg Hospital
  • University of Southern Denmark

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Dec 23, 2020
Registry last updated
Aug 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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