Trial Outcomes & Findings for Endothelial Function After Cardiac Surgery (NCT NCT02882074)

Results Overview

RHI measures endothelial dysfunction using noninvasive peripheral arterial tonometry (PAT) with the EndoPAT device. It is a ratio of the post-to-pre occlusion PAT amplitude of the tested arm, divided by the post-to-pre occlusion ratio of the control arm. RHI less than 1.67 is considered a sign of endothelial dysfunction and RHI equal to or greater than 1.67 is considered normal function. Increasing score indicates the improvement of coronary endothelial function.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

85 participants

Primary outcome timeframe

2 hours after surgery

Results posted on

2024-02-01

Participant Flow

Participant milestones

Participant milestones
Measure	Human Albumin Human albumin 5% during surgery. Human albumin: human albumin 5% during surgery	Hydroxyethyl Starch Hydroxyethyl starch 6% (130/0.4) solution during surgery Hydroxyethyl starch: 6% Hydroxyethyl starch 130/0.4 during surgery
Overall Study STARTED	43	42
Overall Study COMPLETED	43	42
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Endothelial Function After Cardiac Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Human Albumin n=43 Participants Human albumin 5% during surgery. Human albumin: human albumin 5% during surgery	Hydroxyethyl Starch n=42 Participants Hydroxyethyl starch 6% (130/0.4) solution during surgery Hydroxyethyl starch: 6% Hydroxyethyl starch 130/0.4 during surgery	Total n=85 Participants Total of all reporting groups
Age, Continuous	69 years STANDARD_DEVIATION 7 • n=5 Participants	68 years STANDARD_DEVIATION 10 • n=7 Participants	69 years STANDARD_DEVIATION 6 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	16 Participants n=7 Participants	34 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	26 Participants n=7 Participants	51 Participants n=5 Participants
Race/Ethnicity, Customized White	41 Participants n=5 Participants	38 Participants n=7 Participants	79 Participants n=5 Participants
Race/Ethnicity, Customized Not White	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Body Mass Index (BMI)	30 kg/m2 STANDARD_DEVIATION 5 • n=5 Participants	30 kg/m2 STANDARD_DEVIATION 6 • n=7 Participants	30 kg/m2 STANDARD_DEVIATION 4 • n=5 Participants

PRIMARY outcome

Timeframe: 2 hours after surgery

Population: The primary endpoint, the Reactive Hyperaemia Index measured within 2 hours of ICU arrival, was missing in 12 patients from the albumin group and 8 patients from the HES group, related to the inability to obtain good quality Reactive Hyperaemia Index measurement most commonly due to movement or other artifacts. The missing primary endpoint was independent of randomization (p=0.34).

RHI measures endothelial dysfunction using noninvasive peripheral arterial tonometry (PAT) with the EndoPAT device. It is a ratio of the post-to-pre occlusion PAT amplitude of the tested arm, divided by the post-to-pre occlusion ratio of the control arm. RHI less than 1.67 is considered a sign of endothelial dysfunction and RHI equal to or greater than 1.67 is considered normal function. Increasing score indicates the improvement of coronary endothelial function.

Outcome measures

Outcome measures
Measure	Human Albumin n=31 Participants Human albumin 5% during surgery. Human albumin: human albumin 5% during surgery	Hydroxyethyl Starch n=34 Participants Hydroxyethyl starch 6% (130/0.4) solution during surgery Hydroxyethyl starch: 6% Hydroxyethyl starch 130/0.4 during surgery
Reactive Hyperemia Index (RHI)	1.88 ratio Standard Deviation 0.80	1.61 ratio Standard Deviation 0.71

SECONDARY outcome

Timeframe: 1 hour after surgery, 24 hours after surgery

Population: Of 141 patients in the primary clinical trial (NCT02192502), 85 patients consented to the measurement of the Reactive Hyperaemia Index. For secondary outcomes, laboratory markers were measured in the initial 141 patients (N=72 albumin, 69 hydroxyethyl starch). Syndecan 1 hour after surgery was missing in 3 patients from the albumin group and 3 patients from the HES group. Syndecan 24 hours after surgery was missing in 4 patients from the albumin group and 4 patients from the HES group.

Blood samples will be obtained at specified times

Outcome measures

Outcome measures
Measure	Human Albumin n=69 Participants Human albumin 5% during surgery. Human albumin: human albumin 5% during surgery	Hydroxyethyl Starch n=66 Participants Hydroxyethyl starch 6% (130/0.4) solution during surgery Hydroxyethyl starch: 6% Hydroxyethyl starch 130/0.4 during surgery
Plasma Concentrations of Syndecan Syndecan 1 hour after surgery	684 ng/mL Interval 307.0 to 1249.0	746 ng/mL Interval 391.0 to 1499.0
Plasma Concentrations of Syndecan Syndecan 24 hours after surgery	282 ng/mL Interval 94.0 to 846.0	344 ng/mL Interval 102.0 to 1071.0

SECONDARY outcome

Timeframe: 1 hour after surgery, 24 hours after surgery

Population: Of 141 patients in the primary clinical trial (NCT02192502), 85 patients consented to the measurement of the Reactive Hyperaemia Index. For secondary outcomes, laboratory markers were measured in the initial 141 patients (N=72 albumin, 69 hydroxyethyl starch). Endocan 1 hour after surgery was missing in 1 patient from the albumin group and 2 patients from the HES group. Endocan 24 hours after surgery was missing in 3 patients from the albumin group and 4 patients from the HES group.

Blood samples will be obtained at specified times

Outcome measures

Outcome measures
Measure	Human Albumin n=71 Participants Human albumin 5% during surgery. Human albumin: human albumin 5% during surgery	Hydroxyethyl Starch n=67 Participants Hydroxyethyl starch 6% (130/0.4) solution during surgery Hydroxyethyl starch: 6% Hydroxyethyl starch 130/0.4 during surgery
Plasma Concentrations of Endocan endocan 1 hour after surgery	280 pg/mL Interval 163.0 to 451.0	233 pg/mL Interval 158.0 to 444.0
Plasma Concentrations of Endocan endocan 24 hours after surgery	154 pg/mL Interval 70.0 to 323.0	132 pg/mL Interval 51.0 to 333.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 hours after surgery

Population: The secondary endpoint, the Reactive Hyperaemia Index measured within 24 hours of ICU arrival, was missing in 19 patients from the albumin group and 21 patients from the HES group, related to the inability to obtain good quality Reactive Hyperaemia Index measurement most commonly due to movement or other artifacts.

RHI measures endothelial dysfunction using noninvasive peripheral arterial tonometry (PAT) with the EndoPAT device. It is a ratio of the post-to-pre occlusion PAT amplitude of the tested arm, divided by the post-to-pre occlusion ratio of the control arm. RHI less than 1.67 is considered a sign of endothelial dysfunction and RHI equal to or greater than 1.67 is considered normal function. Increasing score indicates the improvement of coronary endothelial function.

Outcome measures

Outcome measures
Measure	Human Albumin n=24 Participants Human albumin 5% during surgery. Human albumin: human albumin 5% during surgery	Hydroxyethyl Starch n=21 Participants Hydroxyethyl starch 6% (130/0.4) solution during surgery Hydroxyethyl starch: 6% Hydroxyethyl starch 130/0.4 during surgery
Reactive Hyperemia Index (RHI)	2.22 ratio Standard Deviation 0.68	1.60 ratio Standard Deviation 0.62

Adverse Events

Human Albumin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Hydroxyethyl Starch

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. Marta Kelava

Cleveland Clinic

Phone: 2162133218

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place