Trial Outcomes & Findings for Impact of Fluid Restriction Policy in Reducing the Use of Red Cells in Cardiac Surgery (NCT NCT00600704)

NCT ID: NCT00600704

Last Updated: 2011-06-07

Results Overview

Recruitment status

COMPLETED

Study phase

Target enrollment

192 participants

Primary outcome timeframe

20 months

Results posted on

2011-06-07

Participant Flow

This prospective study was conducted in our University Hospital over a 20-month period, after approval from the Institution Ethics committee, and written informed consent was obtained from all patients before entering the study. All the participants were patients of the Cardio-Thoracic Clinic of our Hospital.

Exclusion criteria were emergency or re-do operations, operations starting after 18.00, administration of tissue plasminogen activator (TPA) or other thrombolytic medications, pre-existing hematologic disease or coagulation abnormality, advanced cirrhosis, renal failure, preoperative blood product transfusion, combined cardiac and carotid surgery.

Participant milestones

Participant milestones
Measure	RESTRICTED FLUIDS Infusion of Hes 130/0.4 up to 500 ml	FREE FLUIDS Free fluid infusion unless Hb\< 6g/dl(allogenic blood use)
Overall Study STARTED	100	92
Overall Study COMPLETED	100	92
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Impact of Fluid Restriction Policy in Reducing the Use of Red Cells in Cardiac Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	RESTRICTED FLUIDS n=100 Participants Infusion of Hes 130/0.4 up to 500 ml	FREE FLUIDS n=92 Participants Free fluid infusion unless Hb\< 6g/dl(allogenic blood use)	Total n=192 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	100 Participants n=5 Participants	92 Participants n=7 Participants	192 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	66 years STANDARD_DEVIATION 7.9 • n=5 Participants	65.5 years STANDARD_DEVIATION 8.3 • n=7 Participants	65.77 years STANDARD_DEVIATION 8.1 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	16 Participants n=7 Participants	33 Participants n=5 Participants
Sex: Female, Male Male	83 Participants n=5 Participants	76 Participants n=7 Participants	159 Participants n=5 Participants
Region of Enrollment Greece	100 participants n=5 Participants	92 participants n=7 Participants	192 participants n=5 Participants

PRIMARY outcome

Timeframe: 20 months

Population: Patients between ages 18-85 undergoing elective cardiac surgery under cardiopulmonary bypass

Outcome measures

Outcome measures
Measure	RESTRICTED FLUIDS n=113 PRC Units Infusion of Hes 130/0.4 up to 500 ml	FREE FLUIDS n=176 PRC Units Free fluid infusion unless Hb\< 6g/dl(allogenic blood use)
Mean Number of Packed Red Cells Units Transfused During Hospital Stay	1.13 packed red cells units Interval 0.9 to 1.36	1.91 packed red cells units Interval 1.63 to 2.19

Adverse Events

RESTRICTED FLUIDS

Serious events: 20 serious events

Other events: 2 other events

Deaths: 0 deaths

FREE FLUIDS

Serious events: 18 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	RESTRICTED FLUIDS n=100 participants at risk Infusion of Hes 130/0.4 up to 500 ml	FREE FLUIDS n=92 participants at risk Free fluid infusion unless Hb\< 6g/dl(allogenic blood use)
Cardiac disorders myocardial infraction	5.0% 5/100 • Number of events 5	4.3% 4/92 • Number of events 4
Cardiac disorders persistent significant arrythmia	8.0% 8/100 • Number of events 8	6.5% 6/92 • Number of events 6
Congenital, familial and genetic disorders low output syndrome	6.0% 6/100 • Number of events 6	7.6% 7/92 • Number of events 7
Nervous system disorders persistent neurological dysfunction	1.0% 1/100 • Number of events 1	0.00% 0/92
Vascular disorders lower extremity ischemia	0.00% 0/100	1.1% 1/92 • Number of events 1

Other adverse events

Other adverse events
Measure	RESTRICTED FLUIDS n=100 participants at risk Infusion of Hes 130/0.4 up to 500 ml	FREE FLUIDS n=92 participants at risk Free fluid infusion unless Hb\< 6g/dl(allogenic blood use)
Surgical and medical procedures reoperation for bleeding	100.0% 1/1 • Number of events 1	100.0% 1/1 • Number of events 1
Renal and urinary disorders renal failure	100.0% 1/1 • Number of events 1	100.0% 1/1 • Number of events 1

Additional Information

Dr Athina Kleitsaki

Larissa University Hospital Dept. of Anesthesiology

Phone: 00306948481865

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place