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Optimising Circulatory Blood Volume after Aneurysmal Subarachnoid Hemorrhage.


- candidate number3133
- NTR NumberNTR1255
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR22-mrt-2008
- Secondary IDs05/240 METC UMC Utrecht
- Public TitleOptimising Circulatory Blood Volume after Aneurysmal Subarachnoid Hemorrhage.
- Scientific TitleOptimising Circulatory Blood Volume after Aneurysmal Subarachnoid Hemorrhage.
- ACRONYMOptica
- hypothesisHypovolemia occurs frequently after aneurysmal subarachnoid hemorrhage and is associated with poor outcome. Current standard practice is to guide fluid therapy on daily fluid balances and/or blood pressures to maintain normovolemia. These parameters are however poorly related to actual blood volume. Optica is a study done to access whether guiding fluid management on daily measurements of blood volume is more effective in maintaining normovolemia and preventing hypovolemia after SAH than standard fluid balance guided therapy.
- Healt Condition(s) or Problem(s) studiedSubarachnoid hemorrhage (SAH), Subarachnoid hemorrhage (SAH), Cerebral aneurysm, Blood volume
- Inclusion criteria1. Aneurysmal subarachnoid hemorrhage;
2. Admitted to UMC Utrecht within 72 hours after the SAH.
- Exclusion criteria1. Imminent death;
2. Liver failure;
3. Kidney failure;
4. Pregnancy;
5. Possible allergy to indocyanine green;
6. Accompanying head injury.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 1-jan-2006
- planned closingdate31-dec-2007
- Target number of participants100
- InterventionsMeasurement of circulating blood volume (CBV) is performed daily in all included patients, by means of Pulse Dye Densitometry. Patients in the intervention group (n=50) have fluid management based on the daily measurements of CBV. Patients in the control group (n=50) have fluid management based on 4-times daily calculations of the fluid balance.
- Primary outcomeThe occurrence of severe hypovolemia, defined as CBV < 50 ml/kg.
- Secondary outcomeThe relation between CBV values and the presence of delayed cerebral ischemia, pulmonary edema, and the use of inotropic support.
- TimepointsMonth 1-2 Preparation
Month 3-21 Recruitment
Month 9-12 and 20-22 Analysis
Month 10-12 and 22-24 Reporting.
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESDr. Reinier G. Hoff
- CONTACT for SCIENTIFIC QUERIESDr. Reinier G. Hoff
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development, University Medical Center Utrecht (UMCU), Department of Perioperative & Emergency Care
- PublicationsRG Hoff, GW van Dijk, A Algra, CJ Kalkman, GJE Rinkel. Fluid balance and blood volume measurement after aneurysmal subarachnoid hemorrhage. Neurocritical Care 2008; DOI 10.1007/s12028-007-9043-x.
- Brief summaryOptica is a prospective controlled study in patients with subarachnoid hemorrhage to determine whether a fluid policy based on daily measurements of the circulating blood volume is more effective in maintaining normovolemia and preventing hypovolemia than standard fluid management, based on calculations of the fluid balance.
- Main changes (audit trail)
- RECORD22-mrt-2008 - 1-feb-2010


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