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NCT01127152: ARIBA
Assessment of Automatic Relays by Intensive Basis Advantage Compared With Manual Relays, on the Hypotension Risks, During Noradrenalin Administration
NA trial testing Measure of arterial pressure in Hypotension in 50 participants. Completed in 1 April 2011.
1 February 2011
Quick facts
| Lead sponsor | Centre Hospitalier Departemental Vendee |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 50 |
| Start date | 1 June 2009 |
| Primary completion | 1 February 2011 |
| Estimated completion | 1 April 2011 |
| Sites | 1 location across France |
Drugs / interventions tested
- Measure of arterial pressure
Conditions studied
- Hypotension — all drugs for Hypotension →
Sponsor
Centre Hospitalier Departemental Vendee
Who can join
18 and older, any sex, with Hypotension. 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.
-
Hypotension occurence defined as a decrease of 20% of the medium arterial pressure(MAP) between the baseline (MAP before the relay) and the minimal MAP in the fifteen minutes after the relay.
Time frame: every five minutes during the thirty minutes before the relay, during the fifteen minutes after the relay
Sponsor's own description
Circulatory failures are the main cause of admissions in the intensive care unit. It is recommended to prescribe to these patients an intravenous injection of catecholamine to correct this dysfunction and to keep an hemodynamic stability. Electric pumps are used to administrate a continuous flow of drugs to patient. When a syringe of drugs ends, it is replaced by a full syringe, it is named "relay". This change may cause a flow interruption and hypotension. In the intensive care unit at departmental hospital (CHD) Vendee, the manual relays used in common practice will cause hemodynamic instabilities : hypotensions in 20% cases. Since 4 years, new devices are also used to make the relays. It is "smart pumps" allowing to manage automated the drug delays. This new method allows to not interrupt the drug flow. It could reduce the occurence of hypotension. A 50% decrease of relative number of hypotension will show that the use of automatic method is the most sure medical strategy. Our study want to compare manual and automatic method watching the variations of medium arterial pressure (MAP) during the fifteen minutes after the relay compared to baseline (MAP before the relay). Noradrenalin is the catecholamine most administrated so we choose to study only the relay for this drug.
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 NCT01127152
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Trials by the same sponsor.
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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 NCT01127152 (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 Centre Hospitalier Departemental Vendee
- Last refreshed: 14 November 2025
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/NCT01127152.
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