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

NCT05585866 | Active Not Recruiting FDA Drug

• 1 other identifier: PROSACC2021
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Acute Kidney Injury; Cancer Colorectal

Keywords

sevoflurane; propofol; plasma creatinine

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• AKI incidence in the cardiovascular disease population

  Within 10 days of surgery

• Association of sex on AKI incidence

  Within 10 days of surgery

• Association of age on AKI incidence

  Within 10 days of surgery

Study Arms (2)

Sevoflurane

The group of patients which received sevoflurane as randomized anesthetic modality.

Drug: Anesthesia Agent

Propofol

The group of patients which received propofol as randomized anesthetic modality.

Drug: Anesthesia Agent

Interventions

Anesthesia Agent DRUG

The two anesthetic modalities included intravenous propofol anesthesia and sevoflurane gas anesthesia administered according to standard clinical praxis.

Propofol; Sevoflurane

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who underwent colorectal cancer resection surgery and gave consent to participate in the CAN trial.

You may qualify if:

• colorectal surgery and participant in the CAN trial

You may not qualify if:

• missing blood samples

Sponsors & Collaborators

• Uppsala University: lead

Study Sites (1)

Uppsala University

Uppsala, 75185, Sweden

Location

MeSH Terms

Conditions

Acute Kidney Injury; Colonic Neoplasms

Interventions

Anesthetics

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2022
• First Posted: October 19, 2022
• Study Start: November 22, 2021
• Primary Completion: October 31, 2022
• Study Completion: December 31, 2025
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)