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

Acute Kidney Injury Clinical Trial

— PROSACC  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05585866
• Other study ID #: PROSACC2021
• Status: Active, not recruiting
• Start date: November 22, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 4000
• Est. completion date: December 31, 2025
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• colorectal surgery and participant in the CAN trial

Exclusion Criteria:

• missing blood samples

Related Conditions & MeSH terms

• Acute Kidney Injury
• Cancer Colorectal
• Wounds and Injuries

Intervention

Drug:
• Anesthesia Agent
The two anesthetic modalities included intravenous propofol anesthesia and sevoflurane gas anesthesia administered according to standard clinical praxis.

Locations

Country	Name	City	State
Sweden	Uppsala University	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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