Can the use of solutions containing high concentrations of solutes given directly into the blood circulation increase the risk for delirium after cardiac surgery?

Infusion of hypertonic solutions: A risk factor for delirium after cardiac surgery? A randomised double blinded controlled trial. - HSPOD

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-002385-39-SE

Enrollment

200

Registered

2018-11-09

Start date

2018-12-06

Completion date

Unknown

Last updated

2020-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The present investigation aims to investigate the risk of developing delirium after cardiac surgery, when using a hyperosmolar priming solution for cardiopulmonary bypass

Interventions

Trade Name: Mannitol infusion solution (150 mg/ml) Pharmaceutical Form: Infusion Trade Name: Sodium Chloride (4 mmol/ml) Pharmaceutical Form: Concentrate for concentrate for solution for infusion T

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: Are hypertonic solutions a risk factor for delirium after cardiac surgery? ;Secondary Objective: To verify changes in osmolality related to the use of hypertonic solutions and to establish its possible role for postoperative delirium. ;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	—

Measure

Time frame

Main Objective: Are hypertonic solutions a risk factor for delirium after cardiac surgery? ;Secondary Objective: To verify changes in osmolality related to the use of hypertonic solutions and to establish its possible role for postoperative delirium. ;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

Measure	Time frame
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	—

Countries

Sweden

Contacts

Public ContactFredrik Holmner

County Council of Västerbotten

fredrik.holmner@vll.se0460907853650

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026