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NCT04001881
Echocardiography and Spinal Induced Hypotension.
trial testing Transthoracic echocardiography in Spinal Anesthetic Toxicity in 61 participants. Completed in 5 May 2022.
25 April 2022
Quick facts
| Lead sponsor | Attikon Hospital |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 61 |
| Start date | 1 August 2019 |
| Primary completion | 25 April 2022 |
| Estimated completion | 5 May 2022 |
| Sites | 1 location across Greece |
Drugs / interventions tested
- Transthoracic echocardiography
- Spinal anesthesia — full drug profile →
Conditions studied
- Spinal Anesthetic Toxicity — all drugs for Spinal Anesthetic Toxicity →
Sponsor
Attikon Hospital
Who can join
Adults 70 to 100, any sex, with Spinal Anesthetic Toxicity. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Modern guidelines have combined both the maximum diameter of IVC at expiration (dIVC max) and the IVCCI to appreciate right atrial pressure (RAP) measurements and consequently to assess intravascular volume status. In fact, IVC diameter \<2.1 cm with IVCCI \>20% (quite inspiration) suggests normal RAP of 3mmHg (range, 0-5mmHg), whereas IVC diameter \>2.1 cm with IVCCI\<20% suggests high RAP of 15mmHg (range, 10-20mmHg). In occasions where the IVC diameter and collapse is not fit the above categories, an intermediate value of 8 mmHg (range, 5-10 mmHg) is applied. From a clinical standpoint, it is conceivable that both measurements must be measured in isolation to enable RAP assessment. To circumvent this limitation the two indices have been consolidated to dIVCmax-to-IVCCI ratio. Although this ratio has been shown high accuracy to predict spinal-induced hypotension in elderly patients with preserved ejection fraction (EF) of the left ventricle (LV), its value in patients with cardiac dysfunction and reduced LV-EF has not been investigated. From the aforementioned, this study sets out to address the role of dIVCmax-to-IVCCI ratio in the prediction as well as in the management of hypotension after spinal anesthesia in elderly orthopaedic patients with reduced LV-EF.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04001881
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04001881 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Attikon Hospital
- Last refreshed: 12 May 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04001881.
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