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

NCT04681508 — Not applicable, Active not recruiting, 600 participants, Nordsjaellands Hospital

ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  

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

RegistryNCT04681508
StatusActive not recruiting
PhaseNot applicable
Study typeInterventional; na, single group, masking: none, diagnostic
Enrollment600 (Estimated)
SponsorNordsjaellands Hospital (Other); collaborators: Bispebjerg Hospital, University of Southern Denmark
ConditionsAbdomen, Acute, Myocardial Injury, Acute Kidney Injury, Pulmonary Disease
InterventionsChest CT without contrast enhancement and chest X-ray (Diagnostic test)
Datesstart 2021-03-01, primary completion 2025-07-31 (estimated), completion 2026-12-31 (estimated), first posted 2020-12-23, last updated 2023-08-21
Locations1 site in Denmark

Related Papers Related Patents Related Grants Related Experts
All trials for Abdomen, Acute All trials for Myocardial Injury All trials of Chest CT without contrast enhancement and chest X-ray

-Summary

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

Expand all sections  ·  Collapse all

+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.

+Arms and interventions

ArmTypeInterventionsDescription
All patientsExperimentalDiagnostic Test: Chest CT without contrast enhancement and chest X-rayAll 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
  • 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

+Outcome measures

Primary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (1)

FacilityCityCountryStatus
Nordsjaellands HospitalHillerødDenmark

+Investigators