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

NCT04681508 | Active Not Recruiting

• 1 other identifier: AHA
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Abdomen, Acute; Myocardial Injury; Acute Kidney Injury; Pulmonary Disease

Outcome Measures

Primary Outcomes (7)

• Proportion of patients with myocardial injury af non-cardiac surgery

  Troponin-I above specified level and dynamic changes

  30 days

• Mortality rate

  Postoperative mortality

  30 days

• Mortality rate

  Postoperative mortality

  90 days

• Mortality rate

  Postoperative mortality

  1 year

• Acute kidney Injury

  According to KIDGO criteria

  30 days

• Proportion of patients with pulmonary pathology

  Findings (including incidental) on a chest x-ray and chest CT scan without contrast enhancement

  1 day

• Proportion of patients with pulmonary complications

  Postoperative complications

  30 days

Study Arms (1)

All patients

EXPERIMENTAL

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

Diagnostic Test: Chest CT without contrast enhancement and chest X-ray

Interventions

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

All patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nordsjaellands Hospital: lead
• Bispebjerg Hospital: collaborator
• University of Southern Denmark: collaborator

Study Sites (1)

Nordsjaellands Hospital

Hillerød, 3400, Denmark

Location

MeSH Terms

Conditions

Abdomen, Acute; Acute Kidney Injury; Lung Diseases

Interventions

Diagnostic Imaging

Condition Hierarchy (Ancestors)

Abdominal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Claus A Bertelsen, PhD

  Nordsjaellands Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2020
• First Posted: December 23, 2020
• Study Start: March 1, 2021
• Primary Completion: July 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 21, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)