Trial Outcomes & Findings for Lactated Ringer's Versus 5% Human Albumin: Cardiac Surgical Patients (NCT NCT02654782)

Last Updated: 2019-04-16

Results Overview

Adequate fluid volume plays a major part in maintaining the necessary hemodynamics to prevent organ damage during cardiac surgery. This will be measured by the total volume of fluid administered to the subject from the start of surgery up to 6 hours in the intensive care unit.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

10 participants

Primary outcome timeframe

Start of surgery up to 6 hours into the intensive care unit (ICU)

Results posted on

2019-04-16

Participant Flow

Subjects were recruited at Mayo Clinic in Rochester, Minnesota.

Participant milestones

Participant milestones
Measure	Lactated Ringer's Subjects randomized to Lactated Ringer's for hemodynamic resuscitation. Volume will be decided based off of individual patient needs. Lactated Ringer's: Crystalloid fluid given for hemodynamic resuscitation based off of individual patient needs.	5% Human Albumin Subjects randomized to 5% human albumin for hemodynamic resuscitation. Volume will be decided based off of individual patient needs. 5% Human Albumin: Colloid given for hemodynamic resuscitation based off of individual patient needs.
Overall Study STARTED	5	5
Overall Study COMPLETED	5	5
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Lactated Ringer's Versus 5% Human Albumin: Cardiac Surgical Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lactated Ringer's n=5 Participants Subjects randomized to Lactated Ringer's for hemodynamic resuscitation. Volume will be decided based off of individual patient needs. Lactated Ringer's: Crystalloid fluid given for hemodynamic resuscitation based off of individual patient needs.	5% Human Albumin n=5 Participants Subjects randomized to 5% human albumin for hemodynamic resuscitation. Volume will be decided based off of individual patient needs. 5% Human Albumin: Colloid given for hemodynamic resuscitation based off of individual patient needs.	Total n=10 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	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized White	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Race/Ethnicity, Customized Asian, Indian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: Start of surgery up to 6 hours into the intensive care unit (ICU)

Population: The study was terminated early. This was a student project and the student performing the study left Mayo Clinic and there were no funds to continue study. Targeted enrollment of 40 subjects was not met and data was not analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Calculated throughout the study up to 6 hours in the ICU

Alveolar-arterial gradient will be calculated from arterial blood gases on each patient. This value will be used to compare shunt in each arm.

Outcome measures

Outcome data not reported

Adverse Events

Lactated Ringer's

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

5% Human Albumin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. William C. Oliver, Jr.

Mayo Clinic

Phone: 507-255-4240

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place