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NCT04786652
Fluid Responsiveness: SVV vs esSVV in Mechanically Ventilated and Spontaneously Breathing Patients
NA trial testing estimated stroke volume variation (esSVV, Nihon Kohden, Japan) in Hemodynamic Instability in 32 participants. Completed in 1 December 2021.
1 October 2021
Quick facts
| Lead sponsor | Northern State Medical University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 32 |
| Start date | 20 March 2021 |
| Primary completion | 1 October 2021 |
| Estimated completion | 1 December 2021 |
| Sites | 1 location across Russia |
Drugs / interventions tested
- estimated stroke volume variation (esSVV, Nihon Kohden, Japan)
- Assessment of fluid responsiveness in mechanically ventilated patients after OPCAB
- Assessment of fluid responsiveness in spontaneously breathing patients at 18 hrs of the postoperative period
Conditions studied
- Hemodynamic Instability — all drugs for Hemodynamic Instability →
- Postoperative Complications — all drugs for Postoperative Complications →
Sponsor
Northern State Medical University
Who can join
Adults 18 to 80, any sex, with Hemodynamic Instability or Postoperative Complications. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Postoperative period after off-pump coronary artery bypass grafting (OPCAB) can be a challenging area for emerging methods for less-invasive continuous hemodynamic monitoring. The primary goal of this study is to assess the accuracy of estimated stroke volume variation (esSVV, Nihon Kohden, Japan) compared with SVV determined by conventional pulse contour analysis (SVVPCA), respectively. All the measurements and tests will be performed: 1. In mechanically ventilated patients after OPCAB within two hrs after intervention: passive leg raising (PLR), increased PEEP, and mini-fluid load (mFL) tests will be followed by standard fluid load (sFL). Monitoring: SVVPCA, PPVPCA, esSVV, HLI, PVI, pre-ejection fraction (PEP, echocardiography), CIPCA, esCI and CISTD. Transthoracic echocardiography will be performed to assess the volume of heart chambers, ejection fraction and pre-ejection phase (PEP). 2. In spontaneously breathing patients at 18 hrs of the postoperative period: PLR, and mFL tests followed by sFL. Monitoring: SVVPCA, PPVPCA, esSVV, PVI, PEP, CIPCA, esCI and CISTD. Transthoracic echocardiography will be performed to assess the volume of heart chambers, ejection fraction and pre-ejection phase.
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 NCT04786652
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Northern State Medical University trials
Trials by the same sponsor.
- NCT05517109 — Hemodynamic in Postreperfusion Period and Functional Recovery in Acute Ischemic Stroke Patients · NA · completed
- NCT04325685 — The Effect of Supraglottic and Oropharyngeal Decontamination on the Incidence of Ventilator-associated Pneumonia · NA · completed
- NCT04323150 — The Effect of Closed Suction System on the Incidence of Ventilator-associated Pneumonia. · NA · completed
- NCT06332768 — NIV Versus HFO Versus Standard Therapy Immediately After Weaning From Mechanical Ventilation in ARDS Patients · NA · completed
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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 NCT04786652 (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 Northern State Medical University
- Last refreshed: 22 March 2024
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/NCT04786652.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing