Condition category
Circulatory System
Date applied
08/02/2007
Date assigned
08/02/2007
Last edited
04/03/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr B M Kors

ORCID ID

Contact details

VU University Medical Centre
Afdeling intensive care volwassenen
Boelelaan 1117
Amsterdam
1081 HV
Netherlands
+ 31 (0)20 444 3900
bm.kors@vumc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Describing the pharmacokinetics of nimodipine, especially the variability of the bio-availability of orally administred nimodipine.

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Interventional, non-randomised, pharmacokinetic study

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Subarachnoidal haemorrhage

Intervention

Blood samples according to strict time protocol during treatment.

Intervention type

Drug

Phase

Not Specified

Drug names

Nimodipine

Primary outcome measures

1. Pharmacokinetics of nimodipine in this specific group of patients
2. Variability of bio-availability of orally administred nimodipine

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/12/2006

Overall trial end date

01/12/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. All patients admitted to the Intensive Care Unit (ICU) with subarachnoidal bleeding/haemorrhage (SAB), treated according to our SAB-protocol
2. Adults aged 18 to 70 years old

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

12

Participant exclusion criteria

1. Pregnancy
2. Expected mortality in less than 24 hours
3. Severe hepatic function disorders
4. Use of medication with known interaction in relation to nimodipine

Recruitment start date

01/12/2006

Recruitment end date

01/12/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

VU University Medical Centre
Amsterdam
1081 HV
Netherlands

Sponsor information

Organisation

VU University Medical Centre (VUMC) (The Netherlands)

Sponsor details

Department of Intensive Care
P.O. Box 7057
Amsterdam
1007 MB
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.vumc.nl/english/

Funders

Funder type

Hospital/treatment centre

Funder name

VU University Medical Centre (VUMC) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes