Renal FailurePhase 1NCT02571426
Renal Function During Pediatric Anesthesia
A Phase 1 study testing Sevoflurane and propofol in people with Renal Failure and Anesthesia, run by Uppsala University at 1 site in Sweden.
Trial summary
It is known that volatile anesthesia, such as sevoflurane, retain water and that this appears more pronounced in children. However, the mechanisms for this effect is unknown and it is not clear if the commonly used anesthetic propofol does the same. Read more about this study
- Who is it for?
- Ages 1 year to 12 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Renal Failure, Anesthesia
- What is being tested?
- Sevoflurane and propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2015to Apr 2019
- Phase
- Phase 1
- 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 1 year to 12 years
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- Eligible for hypospadia surgery.
Who cannot join
- American Association of Anesthesiology class above 2
- Weight above 50 kg or below 10 kg
- Hypersensitivity towards the anesthetic agents (difficult peanut or soy allergy)
- Inability for parent to understand study information
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of Propofol and Sevoflurane Anesthesia on Water and Sodium Retention in Children
It is known that volatile anesthesia, such as sevoflurane, retain water and that this appears more pronounced in children. However, the mechanisms for this effect is unknown and it is not clear if the commonly used anesthetic propofol does the same. In this study the investigators want to compare the fluid and electrolyte conserving effects of sevoflurane and propofol in a pediatric setting and also investigate humoral changes induced by these anesthetics.
Read the detailed description
Prior studies by the investigators research group have shown water and sodium retention in experimental animals undergoing sevoflurane anesthesia. Preliminary data suggest that this is not as obvious with propofol anesthesia. The investigators aim to study if this difference is present in children.
Subjects are collected from ordinary routine operations of hypospadia. By routine, all boys undergoing this surgery get a sacral blockade and a urine catheter. The children are randomized to either sevoflurane or propofol anesthesia. Before or immediately after induction of anesthesia baseline blood samples are collected for analysis of sodium, potassium, creatinine, osmolality, angiotensin II, arginine-vasopressin and aldosterone. Perioperative fluids are started, a balanced glucose infusion with 132mmol sodium content, covering basal fluid need + 20%. This infusion is continued until the end of the protocol at the ward. At the induction of anesthesia the investigators start measuring urine output every 20th minute. The same blood samples as above are collected again during mid-operation. At the end of anesthesia the investigators collect all the urine and send a sample for urine analysis of sodium, potassium, osmolality and creatinine.
In the postoperative ward the investigators again start collecting urine every 20 minutes for 120 minutes. All urine after 120 minutes are collected, and a sample sent for analysis. After 60 minutes at the postoperative ward, blood samples are again collected for analysis.
In the childrens ward the protocol for the postoperative ward is repeated, with urine collection and sample, as well as blood samples. After 120 minutes the protocol ends.
- Conditions
- Renal Failure, Anesthesia
- Being tested
- Sevoflurane, propofol
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
Also called sevorane
anesthetic agent
propofolDrug
Also called diprivane
anesthetic agent
| Study group | Role | What they receive |
|---|---|---|
| Propofol | Active comparator | Continuous infusion during surgery. Individual dosage. Receives: Drug: propofol |
| sevoflurane | Active comparator | Inhalational anesthetic during surgery. Individual dosage Receives: Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
urine output during anesthesia
Measured: 2 hours
Secondary outcomes (5)
urine output postoperatively
Measured: 4 hours
sodium excretion postoperatively
Measured: 4 hours
Changes in aldosterone, angiotensin II, arginine-vasopressin during surgery
Comparison of blood samples of fluid balance regulatory hormones collected at baseline, during surgery and 1 hour + 3 hours postoperatively
Measured: 2 hours
Changes in aldosterone, angiotensin II, arginine-vasopressin postoperatively
Comparison of blood samples of fluid balance regulatory hormones collected at baseline, during surgery and 1 hour + 3 hours postoperatively
Measured: 4 hours
Sodium excretion during anesthesia
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionMar 2018
- Study completionApr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal FailureStudies 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Micael Taavo, Uppsala University
- Investigators
- Micael Taavo, MD, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02571426
- Sponsor's protocol ID
- SRC52320142569-1
- Status last verified
- Nov 2020
- First submitted
- 5 Oct 2015
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Propofol and Sevoflurane Anesthesia on Water and Sodium Retention in Children
- ClinicalTrials.gov ID
- NCT02571426
- Acronym / sponsor ID
- SRC52320142569-1
- Conditions
- Renal Failure, Anesthesia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Mar 2018 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 8 Oct 2015 (estimated)
- 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.
It is known that volatile anesthesia, such as sevoflurane, retain water and that this appears more pronounced in children. However, the mechanisms for this effect is unknown and it is not clear if the commonly used anesthetic propofol does the same. In this study the investigators want to compare the fluid and electrolyte conserving effects of sevoflurane and propofol in a pediatric setting and also investigate humoral changes induced by these anesthetics.
Detailed description
Prior studies by the investigators research group have shown water and sodium retention in experimental animals undergoing sevoflurane anesthesia. Preliminary data suggest that this is not as obvious with propofol anesthesia. The investigators aim to study if this difference is present in children.
Subjects are collected from ordinary routine operations of hypospadia. By routine, all boys undergoing this surgery get a sacral blockade and a urine catheter. The children are randomized to either sevoflurane or propofol anesthesia. Before or immediately after induction of anesthesia baseline blood samples are collected for analysis of sodium, potassium, creatinine, osmolality, angiotensin II, arginine-vasopressin and aldosterone. Perioperative fluids are started, a balanced glucose infusion with 132mmol sodium content, covering basal fluid need + 20%. This infusion is continued until the end of the protocol at the ward. At the induction of anesthesia the investigators start measuring urine output every 20th minute. The same blood samples as above are collected again during mid-operation. At the end of anesthesia the investigators collect all the urine and send a sample for urine analysis of sodium, potassium, osmolality and creatinine.
In the postoperative ward the investigators again start collecting urine every 20 minutes for 120 minutes. All urine after 120 minutes are collected, and a sample sent for analysis. After 60 minutes at the postoperative ward, blood samples are again collected for analysis.
In the childrens ward the protocol for the postoperative ward is repeated, with urine collection and sample, as well as blood samples. After 120 minutes the protocol ends.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol | Active comparator | Drug: propofolContinuous infusion during surgery. Individual dosage. |
| sevoflurane | Active comparator | Drug: SevofluraneInhalational anesthetic during surgery. Individual dosage |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Eligible for hypospadia surgery.
Key exclusion criteria (4 listed)
- American Association of Anesthesiology class above 2
- Weight above 50 kg or below 10 kg
- Hypersensitivity towards the anesthetic agents (difficult peanut or soy allergy)
- Inability for parent to understand study information
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 |
|---|---|---|
| SevofluraneAlso: sevoraneanesthetic agent | Drug | sevoflurane |
| propofolAlso: diprivaneanesthetic agent | Drug | Propofol |
Primary outcome
urine output during anesthesia
Time frame: 2 hours
5 secondary outcomes
urine output postoperatively
Time frame: 4 hours
sodium excretion postoperatively
Time frame: 4 hours
Changes in aldosterone, angiotensin II, arginine-vasopressin during surgery
Time frame: 2 hours
Changes in aldosterone, angiotensin II, arginine-vasopressin postoperatively
Time frame: 4 hours
Sodium excretion during anesthesia
Time frame: 2 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 4 Nov 2020.
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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.
Micael Taavo, MD principal investigator
Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sevoflurane and propofol in people with Renal Failure 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 4 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 4 Nov 2020. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
urine output during anesthesia (time frame: 2 hours). 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 4 Nov 2020; AzTrials last refreshed its copy on 28 Oct 2026.