The Effect of Ketanserin on the Microcirculation in Sepsis
This study is currently recruiting participants.
Verified October 2012 by Medical Centre Leeuwarden
Sponsor:
Medical Centre Leeuwarden
Information provided by (Responsible Party):
E.C. Boerma, Medical Centre Leeuwarden
ClinicalTrials.gov Identifier:
NCT01329887
First received: April 4, 2011
Last updated: October 31, 2012
Last verified: October 2012
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | April 4, 2011 | ||||
| Last Updated Date | October 31, 2012 | ||||
| Start Date ICMJE | March 2011 | ||||
| Estimated Primary Completion Date | April 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
microcirculation [ Time Frame: 2 hours ] [ Designated as safety issue: No ] achievement of a microvascular flow index >2,9 |
||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01329887 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
ketanserine dosage [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ] obtaining a global indication of the ketanserin dosage needed to achieve a MFI >2,9 and the incidence of hypotension |
||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | The Effect of Ketanserin on the Microcirculation in Sepsis | ||||
| Official Title ICMJE | Evaluation of the Effect of Ketanserine on Sublingual Microcirculation by SDF Imaging in Septic Patients on the Intensive Care | ||||
| Brief Summary | This study is an evaluation of the effect of ketanserine on sublingual microcirculation in intensive care patients with severe sepsis. |
||||
| Detailed Description | This is a pilot study, including 10 ICU patients with severe sepsis with MFI < 2,5 after fulfillment of a strict resuscitation protocol. At the start of the study, a baseline SDF measurement is made, when MFI < 2,5 inclusion in the study is permitted and intravenous ketanserin administration is started and subsequently increased, guided by the effect on sublingual MFI, until a safe maximum dosage is reached. Safety margins for hypotension are defined in the study protocol. |
||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
||||
| Condition ICMJE |
|
||||
| Intervention ICMJE | Drug: ketanserin
ketanserin administration is started and increase, guided by the effect on sublingual MFI, dosage is 0,03mg/kg/hr |
||||
| Study Arm (s) | administration of ketanserin
Intervention: Drug: ketanserin |
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 10 | ||||
| Estimated Completion Date | July 2013 | ||||
| Estimated Primary Completion Date | April 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
|
||||
| Location Countries ICMJE | Netherlands | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01329887 | ||||
| Other Study ID Numbers ICMJE | TPO 736 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | E.C. Boerma, Medical Centre Leeuwarden | ||||
| Study Sponsor ICMJE | Medical Centre Leeuwarden | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | Medical Centre Leeuwarden | ||||
| Verification Date | October 2012 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||