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

NCT06206434 | Recruiting DMC

• 1 other identifier: 811
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Fluid Therapy; Dehydration

Outcome Measures

Primary Outcomes (1)

• Number of hypotension events after spinal anesthesia in patients with crystaloids co-loading guided by transthoracic echocardiogrpahy

  Patients with Mean arterial pressure (MAP) ≤ 65 mmHg, or with a reduction ≥ 25% of baseline pre-operative values are considered hypotensive

  Thirty seconds

Interventions

Point of care ultrasonography DIAGNOSTIC_TEST

Transthoracic echocardiogrpahy followed spinal anesthesia and 5 ml/kg Ringers lactate fluid co-loading

Also known as: Fluid-crystaloid co-loading immediately after spinal anesthesia

Eligibility Criteria

• Age: 70 Years - 100 Years
• Sex: all
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study participants; patients who were American Heart Association/American College of Cardiology (AHA/ACC) stage B or C whose cardiac disease status was compensated.

You may qualify if:

• All the included patients have BUN-to-creatinne ratio\>20
• LV-EF between 35% and 50%
• Normal RV function indices \[tricuspid annular plane systolic excursion (TAPSE) index \> 16 and tricuspid annular systolic velocity (TASV) \> 10 cm/sec and fractional area change (FAC) \> 35%)\]

You may not qualify if:

• 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

Sponsors & Collaborators

• Attikon Hospital: lead

Study Sites (1)

Theodosios Saranteas

Athens, Greece

RECRUITING

Related Publications (1)

• Moschovaki N, Saranteas T, Spiliotaki E, Giannoulis D, Anagnostopoulos D, Talliou C, Milionis O, Briassoulis P, Katogiannis K, Papadimos T. Point of care transthoracic echocardiography for the prediction of post - spinal anesthesia hypotension in elderly patients with cardiac diseases and left ventricular dysfunction : Inferior vena cava and post-spinal anesthesia hypotension in elderly patients. J Clin Monit Comput. 2023 Oct;37(5):1207-1218. doi: 10.1007/s10877-023-00981-y. Epub 2023 Feb 21.

  PMID: 36805418 BACKGROUND

MeSH Terms

Conditions

Dehydration

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Theodosios Saranteas, MD, PhD

  University of Athens

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Theodosios Saranteas, MD, PhD

CONTACT

00306973928195; thsaranteas@gmail.com

Study Design

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

Study Record Dates

• First Submitted: December 26, 2023
• First Posted: January 16, 2024
• Study Start: January 2, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)