Urine Output DecreasedNCT06814561
Hemodynamic Determinants of Urine Output During Spinal Anesthesia
An observational study of Urine Output Decreased, run by Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu at 1 site in Romania.
Trial summary
This clinical trial investigates the relationship between urine output and mean arterial pressure (MAP) during spinal anesthesia. The study aims to validate observations from animal models in humans by concurrently measuring hemoglobin levels, MAP, and urine output, focusing on the effects of Ringer's solution, to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urine Output Decreased
- What is being tested?
- Marcaine 0.5% Solution for Injection
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 1 siteRomania
- Study dates
- 30 Jan 2025to 30 Oct 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients requiring spinal anesthesia for vascular surgery.
Who may be able to join
- Written informed consent provided by patients or their legally authorized representatives.
- Adults aged 18 years and older.
Who cannot join
- Contraindications to Spinal Anesthesia:
- Patient refusal
- Presence of coagulopathy.
- Current use of anticoagulant or antiplatelet medications.
- Critical or severe aortic stenosis or other fixed cardiac output states.
- High risk of infection at the spinal needle insertion site.
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- Elevated intracranial pressure.
- Allergy
- Sepsis
- Procedures Not Amenable to Spinal Anesthesia:
- Planned concurrent procedures that cannot be performed under spinal anesthesia.
Trial locations and contacts
1 site in 1 country.
Romania1 site
"Prof CC Iliescu" Emergency Institue for Cardiovascular Diseases
Bucharest, 022328
About this study
This clinical trial investigates the relationship between urine output and mean arterial pressure (MAP) during spinal anesthesia. The study aims to validate observations from animal models in humans by concurrently measuring hemoglobin levels, MAP, and urine output, focusing on the effects of Ringer's solution, to provide crucial insights into optimal fluid management during anesthesia with minimal complexity.
Read the detailed description
The proposed clinical trial aims to explore the relationship between urine output and mean arterial pressure (MAP) during spinal anesthesia, a subject that has not been thoroughly studied in humans despite previous research under general anesthesia. Studies have demonstrated that the diuretic response to intravenous volume loading, using Ringer's solution or 20% albumin, varies with MAP levels. Specifically, Ringer's solution shows a greater diuretic effect when MAP exceeds 70 mmHg, whereas 20% albumin is more effective at lower pressures. This differential response highlights the importance of considering MAP in the choice of fluid for managing hypovolemia and oliguria.
The study's relevance is highlighted by the physiological dynamics at play, particularly how high levels of anesthesia, which influence the sympathetic nervous system from the mid-thoracic region, might reduce MAP and consequently decrease urine output. While this hypothesis has been examined in animal studies, its validity in humans remains unconfirmed.
To address this, the trial will measure hemoglobin levels, MAP, and urine output simultaneously, aiming to establish a clear correlation among these variables during spinal anesthesia. This methodical approach seeks to yield significant insights with minimal additional effort, contrasting with the complexities inherent in more elaborate study designs.
- Conditions
- Urine Output Decreased
- Being tested
- Marcaine 0.5% Solution for Injection
- Keywords
- urine output, spinal anesthesia, mean arterial pressure
- Medical subject headings
- Oliguria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Marcaine 0.5% Solution for InjectionDrug
Also called Bupivacaine
The study involves the administration of 0.5% Marcaine heavy for spinal anesthesia in patients undergoing vascular surgery. The aim is to assess how this anesthesia affects urine output relative to mean arterial pressure.
What is being measured
The primary outcome is the main question the study is designed to answer.
Catheter-Assisted Urine Output Measurement Post-Spinal Anesthesia
Urine volume is accurately measured using a catheter connected to a graduated collection bag. This method tracks the accumulated volume at specific intervals, providing a precise assessment of renal function and fluid management efficacy following spinal anesthesia
Measured: 10, 20, 30, 40, 50, and 60 minutes post-surgical intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start30 Jan 2025
- Primary completion1 Sep 2025
- Study completion30 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urine Output DecreasedStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Balan Ion Cosmin, Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu
- Investigators
- Robert Hahn, Professor, Study chair, Karolinska Institutet: Stockholm, SE (Department of Clinical Sciences, Danderyd Hospital) EmploymentSerban-Ion Bubenek-Turconi, Professor, Study director, CC Iliescu Cardiovascular Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06814561
- Sponsor's protocol ID
- 2511
- Status last verified
- Nov 2025
- First submitted
- 1 Feb 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Determinants of Urine Output During Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT06814561
- Acronym / sponsor ID
- 2511
- Conditions
- Urine Output Decreased
- Keywords
- urine output, spinal anesthesia, mean arterial pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. IliescuUniversity, hospital or other
- Study start
- 30 Jan 2025 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 30 Oct 2025 (actual)
- First posted
- 7 Feb 2025 (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 clinical trial investigates the relationship between urine output and mean arterial pressure (MAP) during spinal anesthesia. The study aims to validate observations from animal models in humans by concurrently measuring hemoglobin levels, MAP, and urine output, focusing on the effects of Ringer's solution, to provide crucial insights into optimal fluid management during anesthesia with minimal complexity.
Detailed description
The proposed clinical trial aims to explore the relationship between urine output and mean arterial pressure (MAP) during spinal anesthesia, a subject that has not been thoroughly studied in humans despite previous research under general anesthesia. Studies have demonstrated that the diuretic response to intravenous volume loading, using Ringer's solution or 20% albumin, varies with MAP levels. Specifically, Ringer's solution shows a greater diuretic effect when MAP exceeds 70 mmHg, whereas 20% albumin is more effective at lower pressures. This differential response highlights the importance of considering MAP in the choice of fluid for managing hypovolemia and oliguria.
The study's relevance is highlighted by the physiological dynamics at play, particularly how high levels of anesthesia, which influence the sympathetic nervous system from the mid-thoracic region, might reduce MAP and consequently decrease urine output. While this hypothesis has been examined in animal studies, its validity in humans remains unconfirmed.
To address this, the trial will measure hemoglobin levels, MAP, and urine output simultaneously, aiming to establish a clear correlation among these variables during spinal anesthesia. This methodical approach seeks to yield significant insights with minimal additional effort, contrasting with the complexities inherent in more elaborate study designs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients requiring spinal anesthesia for vascular surgery.
Key inclusion criteria (2 listed)
- Written informed consent provided by patients or their legally authorized representatives.
- Adults aged 18 years and older.
Key exclusion criteria (11 listed)
- Contraindications to Spinal Anesthesia:
- Procedures Not Amenable to Spinal Anesthesia:
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 |
|---|---|---|
| Marcaine 0.5% Solution for InjectionAlso: BupivacaineThe study involves the administration of 0.5% Marcaine heavy for spinal anesthesia in patients undergoing vascular surgery. The aim is to assess how this anesthesia affects urine output relative to mean arterial pressure. | Drug | – |
Primary outcome
Catheter-Assisted Urine Output Measurement Post-Spinal Anesthesia
Time frame: 10, 20, 30, 40, 50, and 60 minutes post-surgical intervention.
Urine volume is accurately measured using a catheter connected to a graduated collection bag. This method tracks the accumulated volume at specific intervals, providing a precise assessment of renal function and fluid management efficacy following spinal anesthesia
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 28 Nov 2025.
Related trials for Urine Output Decreased
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.
Robert Hahn, Professor study chair
Karolinska Institutet: Stockholm, SE (Department of Clinical Sciences, Danderyd Hospital) Employment
Serban-Ion Bubenek-Turconi, Professor study director
CC Iliescu Cardiovascular Institute
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 Urine Output Decreased, run by Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu at 1 site in Romania.
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 2 inclusion and 11 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 28 Nov 2025. 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 Romania. 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?
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?
Catheter-Assisted Urine Output Measurement Post-Spinal Anesthesia (time frame: 10, 20, 30, 40, 50, and 60 minutes post-surgical intervention.). 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 28 Nov 2025.