Acute Kidney InjuryPROSACCNCT05585866
Propofol and Sevoflurane Anesthesia in Colorectal Cancer Surgery: Incidence of Acute Kidney Injury
An observational study of Acute Kidney Injury and Cancer Colorectal, run by Uppsala University at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Kidney Injury, Cancer Colorectal
- What is being tested?
- Anesthesia Agent
- Type of treatment
- Injection or infusion
- How many people
- 4,000 participants
- Where
- 1 siteSweden
- Study dates
- 22 Nov 2021to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who underwent colorectal cancer resection surgery and gave consent to participate in the CAN trial.
Who may be able to join
- colorectal surgery and participant in the CAN trial
Who cannot join
- missing blood samples
Trial locations and contacts
1 site in 1 country.
About this study
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:
Read more
- 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
- Being tested
- Anesthesia Agent
- Keywords
- sevoflurane, propofol, plasma creatinine
- Medical subject headings
- Acute Kidney Injury, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anesthesia AgentDrug
The two anesthetic modalities included intravenous propofol anesthesia and sevoflurane gas anesthesia administered according to standard clinical praxis.
| Study group | Role | What they receive |
|---|---|---|
| Sevoflurane | The group of patients which received sevoflurane as randomized anesthetic modality. Receives: Drug: Anesthesia Agent | |
| Propofol | The group of patients which received propofol as randomized anesthetic modality. Receives: Drug: Anesthesia Agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Within 30 days of surgery
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Within 10 days of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2022
- Study start22 Nov 2021
- Primary completion31 Oct 2022
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05585866
- Sponsor's protocol ID
- PROSACC2021
- Acronym
- PROSACC
- Status last verified
- May 2024
- First submitted
- 13 Oct 2022
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Propofol and Sevoflurane Anesthesia in Colorectal Cancer Surgery: Incidence of Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT05585866
- Acronym / sponsor ID
- PROSACC / PROSACC2021
- Conditions
- Acute Kidney Injury, Cancer Colorectal
- Keywords
- sevoflurane, propofol, plasma creatinine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- 22 Nov 2021 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 19 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane | – | Drug: Anesthesia AgentThe group of patients which received sevoflurane as randomized anesthetic modality. |
| Propofol | – | Drug: Anesthesia AgentThe group of patients which received propofol as randomized anesthetic modality. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who underwent colorectal cancer resection surgery and gave consent to participate in the CAN trial.
Key inclusion criteria (1 listed)
- colorectal surgery and participant in the CAN trial
Key exclusion criteria (1 listed)
- missing blood samples
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anesthesia AgentThe two anesthetic modalities included intravenous propofol anesthesia and sevoflurane gas anesthesia administered according to standard clinical praxis. | Drug | Propofol, Sevoflurane |
Primary outcome
Acute Kidney Injury
Time frame: Within 10 days of surgery
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.
Changes in plasma creatinine
Time frame: Within 30 days of surgery
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.
3 secondary outcomes
AKI incidence in the cardiovascular disease population
Time frame: Within 10 days of surgery
Association of sex on AKI incidence
Time frame: Within 10 days of surgery
Association of age on AKI incidence
Time frame: Within 10 days of surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury and Cancer Colorectal, run by Uppsala University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute Kidney Injury (time frame: Within 10 days of surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.