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Search / Trial NCT06206434

Point of Care Ultrasound and Co-loading in Patients With Spinal-induced Hypotension and Cardiac Diseases

Launched by ATTIKON HOSPITAL · Jan 12, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying how a specific fluid treatment called "co-loading" can help prevent low blood pressure (hypotension) in elderly patients with heart conditions after they receive spinal anesthesia, which is often used during surgeries like hip repairs. The researchers believe that by using ultrasound to assess certain heart and blood vessel measurements before the procedure, they can identify patients who are more likely to experience low blood pressure. They are particularly looking at patients whose measurements indicate a higher risk, specifically those with a certain ratio related to the inferior vena cava, a large vein that carries blood to the heart.

To be eligible for this trial, participants should be elderly patients who have a specific measurement showing they are at risk for low blood pressure after anesthesia and have a certain level of heart function. They must not have any serious heart valve issues or other complications that could interfere with the study results. If enrolled, participants can expect close monitoring of their heart function and fluid treatment during their surgery to see if it helps maintain stable blood pressure. It's important to note that this study is currently recruiting participants, and they are looking for individuals of all genders aged between 25 and 65.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • All the included patients have dIVCmax-to-IVCCI ratio \< 48,
  • LV-EF between 35% and 50%
  • Normal RV function indices \[tricuspid annular plane systolic excursion (TAPSE) index \> 16 and tricuspid annular systolic velocity (TASV) \> 10 cm/sec and fractional area change (FAC) \> 35%)\]
  • Exclusion Criteria:
  • Poor acoustic windows,
  • Tthose who were included during the initial screening, but they finally found with pulmonary hypertension (peak tricuspid velocity \> 3.4 m/sec), tricuspid/mitral/pulmonary valve regurgitation grade 3 or 4, severe aortic/mitral valve stenosis, and severe mitral annulus calcification on the preoperative echocardiogram.
  • All patients with maximum cephalad dermatomal extension of the spinal sensory block below T12 or arterial hypotension related to overt intraoperative bleeding (\>150 cc) are excluded.
  • Intraoperrative hypotension due to bleeding and cement placement

About Attikon Hospital

Attikon Hospital is a leading medical institution dedicated to advancing healthcare through innovative clinical research. With a strong commitment to patient-centered care, the hospital actively sponsors clinical trials that aim to evaluate new therapeutic interventions and improve treatment outcomes across various medical fields. Attikon Hospital leverages its state-of-the-art facilities and a multidisciplinary team of experienced healthcare professionals to ensure rigorous study design, ethical standards, and comprehensive patient safety. By fostering collaboration among researchers, clinicians, and patients, Attikon Hospital plays a pivotal role in translating scientific discoveries into effective clinical practices.

Locations

Athens, , Greece

Patients applied

0 patients applied

Trial Officials

Theodosios Saranteas, MD, PhD

Principal Investigator

University of Athens

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported