Comparative effect of resuscitation with hypertonic saline versus normal saline after extracorporeal circulation during cardiovascular surgery in the Intensive Care Unit (ICU)

Comparative effect of resuscitation with hypertonic saline versus normal saline on lactate clearance in patients hospitalized in ICU that underwent extracorporeal circulation during valve replacement or coronary artery bypass grafting

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12615000466549

Enrollment

102

Registered

2015-05-13

Start date

2013-04-18

Completion date

2015-01-20

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

This is a randomized double blind controlled trial that compares 7.5% hypertonic saline solution versus normal saline solution, in the resuscitation of the patients that underwent extracorporeal circulation surgery once they arrive in the ICU. The primary endpoint was to assess the lactate clearance within each arm of the study.

Interventions

We administer intravenously infused over 30 minutes Hypertonic Saline with a concentration of 7.5% in a dose of 4 cc x kg of predicted body weight when the patients arrive to the ICU after a replacement valve surgery or a coronary artery bypass graft surgery that underwent extracorporeal circulation.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Patients with signed informed consent older than 18 years old Patients admitted in the ICU after valve replacement surgery or coronary artery bypass surgery that underwent extracorporeal circulation

Exclusion criteria

Patients that withdraw the informed consent by himself or by their family at any time during the intervention Heart transplant surgery Patients that do not fulfill the study protocol

Outcome results