Hemodynamic Determinants of Urine Output During Spinal Anesthesia

NCT06814561 | Completed DMC FDA Drug

• 1 other identifier: 2511
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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 provide crucial insights into optimal fluid management during anesthesia with minimal complexity.

Conditions

Urine Output Decreased

Keywords

urine output; spinal anesthesia; mean arterial pressure

Outcome Measures

Primary Outcomes (1)

• 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

  10, 20, 30, 40, 50, and 60 minutes post-surgical intervention.

Interventions

Marcaine 0.5% Solution for Injection DRUG

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.

Also known as: Bupivacaine

Eligibility Criteria

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

Study Population

Adult patients requiring spinal anesthesia for vascular surgery.

You may qualify if:

• Written informed consent provided by patients or their legally authorized representatives.
• Adults aged 18 years and older.

You may not qualify if:

• 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.
• Elevated intracranial pressure.
• Allergy
• Sepsis
• Procedures Not Amenable to Spinal Anesthesia:
• Planned concurrent procedures that cannot be performed under spinal anesthesia.

Sponsors & Collaborators

• Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu: lead

Study Sites (1)

"Prof CC Iliescu" Emergency Institue for Cardiovascular Diseases

Bucharest, 022328, Romania

Location

MeSH Terms

Conditions

Oliguria

Interventions

Bupivacaine; Solutions; Injections

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pharmaceutical Preparations; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Robert Hahn, Professor

  Karolinska Institutet: Stockholm, SE (Department of Clinical Sciences, Danderyd Hospital) Employment

  STUDY CHAIR

• Serban-Ion Bubenek-Turconi, Professor

  CC Iliescu Cardiovascular Institute

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 1, 2025
• First Posted: February 7, 2025
• Study Start: January 30, 2025
• Primary Completion: September 1, 2025
• Study Completion: October 30, 2025
• Last Updated: November 28, 2025

Record last verified: 2025-11

Locations

RO (1)