Propofol and Sevoflurane Anesthesia in Colorectal Cancer Surgery: Incidence of Acute Kidney Injury

Study Overview
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Brief Summary
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The goal of this observational study is to compare anesthetic modalities (intravenous propofol anesthesia with sevoflurane gas anesthesia) in patients who underwent colorectal cancer resection surgery regarding the outcome of acute kidney injury. The main questions it aims to answer are: is there a difference in acute kidney injury incidence in the two anesthetic modalities? is there a difference in plasma creatinine between the two anesthetic modalities? are there any patient characteristics or intraoperative factors that effect the incidence of acute kidney injury in either anesthetic modality? The study will analyze data from the CAN clinical trial database. (Cancer and Anesthesia: Survival After Radical Surgery - a Comparison Between Propofol or Sevoflurane Anesthesia, NCT01975064)

Official Title
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Propofol and Sevoflurane Anesthesia in Colorectal Cancer Surgery: Incidence of Acute Kidney Injury

Conditions
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Acute Kidney Injury, Cancer Colorectal

Intervention / Treatment
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* Drug: Anesthesia Agent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: colorectal surgery and participant in the CAN trial Exclusion Criteria: missing blood samples
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sevoflurane<br>The group of patients which received sevoflurane as randomized anesthetic modality. | Drug: Anesthesia Agent<br>* The two anesthetic modalities included intravenous propofol anesthesia and sevoflurane gas anesthesia administered according to standard clinical praxis.<br>|
| Propofol<br>The group of patients which received propofol as randomized anesthetic modality. | Drug: Anesthesia Agent<br>* The two anesthetic modalities included intravenous propofol anesthesia and sevoflurane gas anesthesia administered according to standard clinical praxis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Kidney Injury | Compare the incidence of AKI (n, %) in the two anesthetic modalities. Number of participants (n, %) with AKI and number of participants (n, %) with AKI stage 1-3 within the different anesthetic modalities at 0-3 days and 4-10 days postoperatively. KDIGO (Kidney Disease: Improving Global Outcome) criteria for plasma creatinine are used as criteria for AKI. The highest value of plasma creatinine within the time frame will be used to define AKI stage. | Within 10 days of surgery | 
| Changes in plasma creatinine | Changes in plasma creatinine over time in both groups of anesthesia. Plasma creatinine from preoperative, postoperative after 0-3 days, postoperative 4-10 days and after 30 days. Maximum plasma creatinine for each participant at these time point will be used in the regression analysis. | Within 30 days of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AKI incidence in the cardiovascular disease population | Compare the incidence of AKI (n, %) during the two anesthetic modalities in the population with present cardiovascular disease. Classified according to KDIGO AKI stage 1-3 changes in plasma creatinine. The highest value of plasma creatinine within the time frame will be used to define AKI stage. | Within 10 days of surgery | 
| Association of sex on AKI incidence | Compare the incidence of AKI (n, %) in men vs women. This analysis will be done in both groups separately and in the entire population independent of anesthetic modality. | Within 10 days of surgery | 
| Association of age on AKI incidence | Compare the incidence of AKI (n, %) in participants older vs younger than 65. This analysis will be done in both groups separately and in the entire population independent of anesthetic modality. | Within 10 days of surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sevoflurane, propofol, plasma creatinine