Can the use of solutions containing high concentrations of solutes given directly into the blood circulation increase the risk for delirium after cardiac surgery?
Phase 1
- Conditions
- The present investigation aims to investigate the risk of developing delirium after cardiac surgery, when using a hyperosmolar priming solution for cardiopulmonary bypassTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2018-002385-39-SE
- Lead Sponsor
- County Council of Västerbotten
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
•Patients eligible for cardiac surgery requiring cardiopulmonary bypass
•Aged =65 years
•Signed informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200
Exclusion Criteria
•Not fluent in the Swedish language
•Acute surgery within 24 hours of admittance
•Cases requiring profound hypothermia
•Patients deemed not to complete test batteries used to diagnose delirium
•Patients with documented allergic reactions for any of the IMP’s included in this study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Are hypertonic solutions a risk factor for delirium after cardiac surgery?<br><br>;Secondary Objective: To verify changes in osmolality related to the use of hypertonic solutions and to establish its possible role for postoperative delirium. <br>;Primary end point(s): To investigate the effect of using hyperosmolar prime in conjunction with cardiopulmonary bypass related to the risk of developing postoperative delirium verified by test results obtained from test batteries sensitive for detecting delirium executed both before and after surgery;Timepoint(s) of evaluation of this end point: The patient is tested for delirium at admittance to the hospital and repeatedly until the 3rd (+/- 1) postoperative day
- Secondary Outcome Measures
Name Time Method Secondary end point(s): To investigate the effects of using hyperosmolar prime in conjunction with cardiopulmonary bypass related to disturbances of normal osmolality verified by serial perioperative measurement of plasma osmolality;Timepoint(s) of evaluation of this end point: Plasma osmolality measured pre cardiopulmonary bypass and repeated four times thereafter until the 3rd postoperative day