Acute Kidney InjuryPhase 4NCT03336801
The Effect of Propofol or Sevoflurane on Renal Function
A Phase 4 study testing Back Surgery, Propofol and Sevoflurane in people with Acute Kidney Injury and Anesthesia, run by Uppsala University at 1 site in Sweden.
Trial summary
This study investigates the role of the anesthetic agents propofol and sevoflurane on renal function in otherwise healthy patients undergoing basic back surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Kidney Injury, Anesthesia
- What is being tested?
- Back Surgery, Propofol and Sevoflurane
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteSweden
- Study dates
- 1 Sep 2017to 10 Jan 2020
- Phase
- Phase 4
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled back surgery
Who cannot join
- American Association of Anesthesiology class 1-3
- American Heart Association class >3
- BMI >37
- Insulin treated diabetes
- Pregnancy or breast feeding
- Sensistivity/allergy against anesthetic agents
Show all 10Show fewer
- Inadequate understanding about the study
- Depressed kidney function and/or AKI
- Depressed liver function
- Genetic malignant hyperthermia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Propofol and Sevoflurane Anesthesia on Renal Function in Patients Undergoing Back Surgery
This study investigates the role of the anesthetic agents propofol and sevoflurane on renal function in otherwise healthy patients undergoing basic back surgery.
Read the detailed description
Water-sodium homeostasis is central for anyone undergoing surgery, and can therefore affect surgical outcome, level of postoperative care and the length of hospital stay. Too much or too little fluid during surgery can affect the patients negatively. The kidneys play an imperative role in the regulation of water and sodium homeostasis, however there are lack of knowledge in how the anesthesia per se affects renal function. Previous studies have shown that volatile anesthetic agents such as sevoflurane can cause fluid retention. Why this happens is not completely known.
We are now investigating the different affects of sevoflurane and propofol anesthesia on renal function in patients undergoing basic back surgery to elucidate if there is a difference in the risk of developing acute kidney injury.
- Conditions
- Acute Kidney Injury, Anesthesia
- Being tested
- Back Surgery, Propofol, Sevoflurane
- Keywords
- sevoflurane, propofol
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Back SurgeryProcedure or surgery
All patients undergo basic back surgery.
PropofolDrug
Anesthesia on propofol alone.
SevofluraneDrug
Anesthesia on sevoflurane alone.
| Study group | Role | What they receive |
|---|---|---|
| Sevoflurane | Active comparator | Intervention Back surgery and sevoflurane. Receives: Procedure: Back Surgery; Drug: Sevoflurane |
| Propofol | Active comparator | Intervention Back surgery and propofol. Receives: Procedure: Back Surgery; Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in urine output
Urine output (ml/min) changes during anesthesia, in postoperative care and in the ward unit. Changes will be assessed with AKIN RIFLE and by comparison between the different groups.
Measured: 24 hours
Change in serum creatinine levels
Changes in serum creatinine levels during anesthesia, in postoperative care and in the ward unit. Changes will be assessed with AKIN RIFLE and by comparison between the different groups.
Measured: 24 hours
Change in creatinine clearance
Creatinine clearance changes during anesthesia, in postoperative care and in the ward unit. Changes will be assessed with AKIN RIFLE and by comparison between the different groups.
Measured: 24 hours
Secondary outcomes (2)
Changes in electrolytes
Changes in serum and urinary electrolytes (sodium and potassium) will be measured during anesthesia, in postoperative care and in the ward unit.
Measured: 24 hours
Changes in hormone levels
The hormones angiotensin II, anti diuretic hormone and aldosterone will be measured during anesthesia, in postoperative care and in the ward unit.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2017
- Study start1 Sep 2017
- Primary completion10 Jan 2020
- Study completion10 Jan 2020
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.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients are randomized into one of two treatment groups which during surgery receives one of two different anesthetic agents. The two groups are then compared to each other.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- The Swedish Research Council
- Responsible party
- Principal investigator, Robert Frithiof, Uppsala University
- Investigators
- Stephanie Franzén, PhD, Principal investigator, Uppsala University, Department of Anesthesiology and Intensive CareRobert Frithiof, MD PhD, Study director, Uppsala University, Department of Anesthesiology and Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03336801
- Sponsor's protocol ID
- ANIMAL-523-2014-2569
- Status last verified
- Apr 2021
- First submitted
- 6 Nov 2017
- Last updated
- 2 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Propofol and Sevoflurane Anesthesia on Renal Function in Patients Undergoing Back Surgery
- ClinicalTrials.gov ID
- NCT03336801
- Acronym / sponsor ID
- ANIMAL-523-2014-2569
- Conditions
- Acute Kidney Injury, Anesthesia
- Keywords
- sevoflurane, propofol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- The Swedish Research Council
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 10 Jan 2020 (actual)
- Study completion
- 10 Jan 2020 (actual)
- First posted
- 8 Nov 2017 (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.
This study investigates the role of the anesthetic agents propofol and sevoflurane on renal function in otherwise healthy patients undergoing basic back surgery.
Detailed description
Water-sodium homeostasis is central for anyone undergoing surgery, and can therefore affect surgical outcome, level of postoperative care and the length of hospital stay. Too much or too little fluid during surgery can affect the patients negatively. The kidneys play an imperative role in the regulation of water and sodium homeostasis, however there are lack of knowledge in how the anesthesia per se affects renal function. Previous studies have shown that volatile anesthetic agents such as sevoflurane can cause fluid retention. Why this happens is not completely known.
We are now investigating the different affects of sevoflurane and propofol anesthesia on renal function in patients undergoing basic back surgery to elucidate if there is a difference in the risk of developing acute kidney injury.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Patients are randomized into one of two treatment groups which during surgery receives one of two different anesthetic agents. The two groups are then compared to each other.
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane | Active comparator | Procedure: Back Surgery, Drug: SevofluraneIntervention Back surgery and sevoflurane. |
| Propofol | Active comparator | Procedure: Back Surgery, Drug: PropofolIntervention Back surgery and propofol. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Scheduled back surgery
Key exclusion criteria (10 listed)
- American Association of Anesthesiology class 1-3
- American Heart Association class >3
- BMI >37
- Insulin treated diabetes
- Pregnancy or breast feeding
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 |
|---|---|---|
| Back SurgeryAll patients undergo basic back surgery. | Procedure or surgery | Propofol, Sevoflurane |
| PropofolAnesthesia on propofol alone. | Drug | Propofol |
| SevofluraneAnesthesia on sevoflurane alone. | Drug | Sevoflurane |
Primary outcome
Change in urine output
Time frame: 24 hours
Urine output (ml/min) changes during anesthesia, in postoperative care and in the ward unit. Changes will be assessed with AKIN RIFLE and by comparison between the different groups.
Change in serum creatinine levels
Time frame: 24 hours
Changes in serum creatinine levels during anesthesia, in postoperative care and in the ward unit. Changes will be assessed with AKIN RIFLE and by comparison between the different groups.
Change in creatinine clearance
Time frame: 24 hours
Creatinine clearance changes during anesthesia, in postoperative care and in the ward unit. Changes will be assessed with AKIN RIFLE and by comparison between the different groups.
2 secondary outcomes
Changes in electrolytes
Time frame: 24 hours
Changes in hormone levels
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2021.
- 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.
Stephanie Franzén, PhD principal investigator
Uppsala University, Department of Anesthesiology and Intensive Care
Robert Frithiof, MD PhD study director
Uppsala University, Department of Anesthesiology and Intensive Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Back Surgery, Propofol and Sevoflurane in people with Acute Kidney Injury and Anesthesia, 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 10 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: finished, as of the sponsor's last update on 2 Apr 2021. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in urine output (time frame: 24 hours). The study lists 3 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 2 Apr 2021.