Acute Kidney Injury Clinical Trial
Official title:
Myocardial Injury After Non-cardiac Surgery (MINS), Acute Kidney Injury (AKI) and Pulmonary Pathology in Patients Undergoing Acute Abdominal Surgery
Verified date | August 2023 |
Source | Nordsjaellands Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Explorative study to investigate potential predictors of myocardial injury, acute kidney injury and pulmonary disorder after acute high-risk abdominal surgery.
Status | Active, not recruiting |
Enrollment | 600 |
Est. completion date | December 31, 2026 |
Est. primary completion date | July 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Denmark | Nordsjaellands Hospital | Hillerød |
Lead Sponsor | Collaborator |
---|---|
Nordsjaellands Hospital | Bispebjerg Hospital, University of Southern Denmark |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of patients with myocardial injury af non-cardiac surgery | Troponin-I above specified level and dynamic changes | 30 days | |
Primary | Mortality rate | Postoperative mortality | 30 days | |
Primary | Mortality rate | Postoperative mortality | 90 days | |
Primary | Mortality rate | Postoperative mortality | 1 year | |
Primary | Acute kidney Injury | According to KIDGO criteria | 30 days | |
Primary | Proportion of patients with pulmonary pathology | Findings (including incidental) on a chest x-ray and chest CT scan without contrast enhancement | 1 day | |
Primary | Proportion of patients with pulmonary complications | Postoperative complications | 30 days |
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