Last reviewed · How we verify
NCT01311414: NIRSMED
Effect of Cafedrine/Theodrenaline and Urapidil During Carotid Endarterectomy on Cerebral Oxygenation Measured by Near Infrared Spectroscopy
NA trial testing cafedrine/theodrenaline, urapidil in Cerebral Ischemia. Withdrawn.
Quick facts
| Lead sponsor | University Hospital Schleswig-Holstein |
|---|---|
| Phase | NA |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Sites | 1 location across Germany |
Drugs / interventions tested
- cafedrine/theodrenaline, urapidil — full drug profile →
Conditions studied
- Cerebral Ischemia — all drugs for Cerebral Ischemia →
Sponsor
University Hospital Schleswig-Holstein
Who can join
18 and older, any sex, with Cerebral Ischemia. 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.
-
Cerebral oxygenation
Time frame: 1 hour
Outcome measure is change of cerebral oxygenation measured by near-infrared spectroscopy from values at baseline (arterial blood pressure in normal range) to values three minutes after increasing systolic blood pressure above 160 mmHg by intravenous injection of cafedrin/theodrenalin as needed (0,5 - 1 ml).
Sponsor's own description
During clamping of one internal carotid artery for endarterectomy, blood flow through this vessel has to be compensated by collateral arteries including the contralateral internal artery and vertebral arteries. In 7 % of all patients undergoing carotid endarterectomy this collateral flow is not sufficient to maintain adequate cerebral perfusion during clamping and ischemic brain damage is likely to emerge. To maximize cerebral blood flow during clamping, increase of blood pressure is a common procedure and routine at our institution. Increasing blood pressure can be enabled by tapering a mixture of Cafedrine und Theodrenalin (Akrinor®) until the designated blood pressure is reached. After declamping, the blood pressure has to be reduced to normal values to avoid postoperative hyperperfusion syndrome. This is enabled by tapering urapidil until normal blood pressure is achieved. It has been shown that cerebral oxygenation measured by near infrared spectroscopy is reduced by intravenous application of norepinephrine. Otherwise, intravenous nitroglycerine increases cerebral oxygenation during cardiopulmonary bypass. Hence, cafedrine/theodrenalin and urapidil may also have an effect on cerebral perfusion. In this prospective randomized study the effect of cafedrine/theodrenalin and urapidil on cerebral oxygenation measured by near infrared spectroscopy is investigated.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT01311414
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Cerebral Ischemia
Currently open trials in the same condition.
- NCT07324421 — Comparison of Ultrasound Cerebral Perfusion Imaging With Routine Perfusion CT · NA · recruiting
- NCT04696523 — Effect of Xenon on Brain Injury After Aneurysmal Subarachnoid Hemorrhage · Phase 2 · recruiting
- NCT06629116 — Study on the Role of Human Serum Albumin in Large Acute Ischemic Stroke of Anterior Circulation After Thrombectomy · NA · recruiting
- NCT06178419 — Remote Ischemic Conditioning for Cerebral Ischemia in Patients With Takayasu Arteritis (TARIC-1) · NA · recruiting
- NCT04522856 — Anaesthesiological Routine Care for Thrombectomy in Cerebral Ischaemia · recruiting
Other University Hospital Schleswig-Holstein trials
Trials by the same sponsor.
- NCT07591376 — A Reminder App to Improve Physical Activity During Radiotherapy for Lung Cancer - a Pre-study in Healthy Volunteers · NA · completed
- NCT07286747 — Efficacy and Safety of Oral Controlled-release Nicotinic Acid (CIR-NA) for the Remission of Prediabetes. (CONCEPT) · Phase 2 · recruiting
- NCT07380815 — Physical Activity During Radiation Therapy for Lung Cancer · not yet recruiting
- NCT07148336 — Identification of Chemotherapy-induced Peripheral Neuropathy · NA · not yet recruiting
- NCT07444801 — Intervention With Tralokinumab in Patients With Moderate-to-severe Atopic Dermatitis With Genital Impact · recruiting
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 NCT01311414 (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 University Hospital Schleswig-Holstein
- Last refreshed: 21 May 2014
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/NCT01311414.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing