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NCT01898975
Evaluation of Stroke Volume Variation Derived From NICOM as a Predictor of Fluid Responsiveness in Neurosurgical Patients: A Gray Zone Approach
trial testing 500ml fluid loading in Neurological Diseases or Conditions. Withdrawn.
1 January 2014
Quick facts
| Lead sponsor | Samsung Medical Center |
|---|---|
| Status | Withdrawn |
| Study type | OBSERVATIONAL |
| Start date | 1 June 2013 |
| Primary completion | 1 January 2014 |
| Estimated completion | 1 May 2014 |
| Sites | 1 location across South Korea |
Drugs / interventions tested
- 500ml fluid loading
Conditions studied
- Neurological Diseases or Conditions — all drugs for Neurological Diseases or Conditions →
- Fluid Responsiveness — all drugs for Fluid Responsiveness →
- Non Invasive Cardiac Output Monitoring — all drugs for Non Invasive Cardiac Output Monitoring →
- Gray Zone — all drugs for Gray Zone →
Sponsor
Samsung Medical Center
Who can join
Adults 20 to 80, any sex, with Neurological Diseases or Conditions or Fluid Responsiveness. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Stroke volume variation
Time frame: 5min following the end of rapid fluid infusion
5min following the end of rapid fluid infusion: 5 min after the end of fluid loading
Sponsor's own description
Optimal fluid management has been considered as crucial part to determine postoperative outcome and organ function. Recently developed, non invasive cardiac output measurement(NICOM, Cheetah Medical, Portland, OR)has enabled continuous cardiac output(CO) monitoring just by attaching electrode on chest wall. Moreover, CO and SSV derived from NICOM have been demonstrated as predictors of fluid responsiveness. Therefore, the aim of this study is to evaluate stroke volume variation derived from NICOM as a predictor of fluid responsiveness in neurosurgical patients. In addition, we plan to reveal inconclusive patients using gray zone approach.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT01898975
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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 NCT01898975 (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 Samsung Medical Center
- Last refreshed: 26 May 2016
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