CompletedPhase 2ACTRN12620000137998

20% Human Albumin Solution Fluid Bolus Administration Therapy in Patients after Cardiac Surgery-II

20% Human Albumin Solution Fluid Bolus Administration Therapy in Patients after Cardiac Surgery-II (HAS FLAIR-II): a phase II multicentre randomised controlled trial to determine whether fluid resuscitation with 20% albumin (Albumex®20) in patients after cardiac surgery decreases the duration of vasopressor requirement compared to usual care.

Sponsor

Austin Health

Enrollment

480 participants

Start Date

Aug 31, 2020

Study Type

Interventional

Conditions

Cardiac Surgery

Summary

HAS FLAIR-II is a multi-centre, randomised controlled trial, looking at patients who require fluid bolus therapy (FBT) after cardiac surgery. FBT after cardiac surgery is a common intervention used to correct hypotension +/- optimise cardiac function. There are several types of intravenous fluid used for fluid resuscitation, which are broadly classified into crystalloids and colloids. After cardiac surgery, patients receive a combination of crystalloid and the colloid albumin in the form of 4% albumin. 20% albumin corrects low blood volume more rapidly and requires less volume to do so than crystalloid fluids and 4% albumin, and by doing so reduces the amount of chloride and fluid the body receives. This may avoid harm associated with chloride and large fluid administrations. Participants will be allocated in a 1:1 ratio to either the treatment group (FBT with 20% albumin) or to usual care (FBT with whatever fluid the treating clinicians consider appropriate and no use of 20% albumin in the first 7 days). We will evaluate the duration of vasopressor use in those who received 20% albumin compared to those that received usual care. We plan to enroll 470 patients post cardiac surgery from Intensive Care Units in Australia.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria1

The treating clinician wishes to administer fluid bolus therapy (FBT) after cardiac surgery.

Exclusion Criteria8

Age less than 18 years
Pregnancy
Patients who have previously received a FBT prescribed in the ICU after cardiac surgery (NB patients who have received FBT in the ICU prior to surgery remain eligible).
Contraindication to study fluid e.g. patients with known or suspected allergy to albumin or crystalloid fluid
Documented refusal of any study fluid (i.e. a patient may refuse to receive Human Albumin Solution which is in 20% and 4% albumin)
Death is deemed to be imminent or inevitable during this admission, and either the attending physician, patient or substitute decision-maker is not committed to active treatment
Off pump cardiac surgery
Patient who have previously been enrolled in this study

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Interventions

Intravenous fluid bolus therapy (FBT)* with 20% albumin will administered by the treating team until one of the following criteria for treatment cessation is met: - Initial (index) vasopressor depen

Intravenous fluid bolus therapy (FBT)* with 20% albumin will administered by the treating team until one of the following criteria for treatment cessation is met: - Initial (index) vasopressor dependence resolves [The resolution of vasopressor dependence is defined as the patient being alive and all vasopressors being discontinued for at least 4 consecutive hours in the presence of a MAP>65 mmHg, or a target MAP set by the clinician in charge of the patient’s care, during the index vasopressor period (subsequent vasopressor periods will not contribute to the primary outcome)] - Patient is discharged from ICU - 7 days have passed since randomisation - Contraindications to 20% albumin or crystalloid therapy arise - Death occurs - Serious adverse events suspected to be related to a study medication develops *FBT will be defined as a volume of at least 100 mL of intravenous fluid administered over one hour or less at a rate of 2 ml/min or greater to increase or maintain intravascular volume. The FBT would be in addition to maintenance fluids, or specific fluids used to replace non-physiological fluid losses. N.B FBT is a common intervention for the optimisation of cardiac output and the treatment of hypotension after cardiac surgery. However there are no consensus diagnostic criteria to identify whether a patient is appropriate for FBT after being admitted to ICU following cardiac surgery. Thus, the decision to administer FBT is based on clinical judgment.