Actively Recruiting

Age: 70Years - 100Years
All Genders
NCT06206434

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

Led by Attikon Hospital · Updated on 2025-11-19

60

Participants Needed

1

Research Sites

130 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

In elderly patients with cardiac diseases, changes in cardiovascular physiology diminish cardiovascular reserve and predispose to significant hemodynamic instability after spinal anesthesia; hence, such patients could be at risk of postoperative complications. Additionally, point of care ultrasound (POCUS) and transthoracic echocardiography (TTE) are used in clinical practice to evaluate cardiovascular hemodynamics. Inferior vena cava (IVC) and its collapsibility index (CI) have been used in clinical practice for the prediction of post-spinal hypotension. Specifically, the dIVCmax-to-IVCCI ratio \< 48 showed high diagnostic performance among other indices in the prediction of post spinal hypotension in elderly patients with cardiac diseases undergoing proximal fracture repair. Elderly patients also experience high likelihood of dehydration. According to the above findings, the investigators hypothesized that fluid co-loading immediately after spinal anesthesia can lower the incidence of spinal-induced hypotension in dehydrated patients. . For this reason, it is prospectively evaluated echocardiographic indices of the LV and the right ventricle (RV), as well as of the IVC prior to spinal anesthesia in elderly patients with proximal femur fractures who had low LV-EF and increased ratio of BUN-to-creatinine.

CONDITIONS

Official Title

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

Who Can Participate

Age: 70Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 70 to 100 years
  • Blood urea nitrogen (BUN) to creatinine ratio greater than 20
  • Left ventricular ejection fraction between 35% and 50%
  • Normal right ventricular function indices: TAPSE > 16, TASV > 10 cm/sec, and FAC > 35%
Not Eligible

You will not qualify if you...

  • Poor ultrasound acoustic windows
  • Pulmonary hypertension with peak tricuspid velocity over 3.4 m/sec
  • Severe tricuspid, mitral, or pulmonary valve regurgitation grade 3 or 4
  • Severe aortic or mitral valve stenosis
  • Severe mitral annulus calcification
  • Maximum spinal sensory block below T12
  • Arterial hypotension due to significant intraoperative bleeding (>150 cc)
  • Hypotension caused by bleeding or cement placement during surgery

AI-Screening

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Trial Site Locations

Total: 1 location

1

Theodosios Saranteas

Athens, Greece

Actively Recruiting

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Research Team

T

Theodosios Saranteas, MD, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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