Endothelial Function After Cardiac Surgery
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 40 - 85 |
| Updated: | 8/12/2018 |
| Start Date: | June 2016 |
| End Date: | June 2019 |
| Contact: | Roberta Johnson |
| Email: | JOHNSOR13@ccf.org |
| Phone: | 216 444-9950 |
Does Plasma Volume Replacement With 5% Human Albumin Reduce Endothelial Injury and Glycocalyceal Disruption Compared With 6% Hydroxyethylstarch (130/0.4) in Patients Having Cardiac Surgery? A Substudy of the SHARP Clinical Trial
The purpose of this study is to evaluate whether patients receiving human albumin for plasma
volume replacement during cardiac surgery have improved postoperative endothelial function
compared to patients receiving 6% hydroxyethyl starch solutions. The postoperative
endothelial function, measured with peripheral arterial tonometry as reactive hyperemia index
(RHI) within 2 hours following surgery, will be compared in cardiac surgical patients
randomized to receive human albumin or 6% HES solutions for intraoperative volume
replacement. Within two hours of arrival to the ICU peripheral arterial tonometry using
EndoPAT will be performed. In a subset of 40 consecutive patients the investigators will
perform additional EndoPAT measurements to describe the expected changes that occur in
endothelial function during the perioperative period (baseline, early postoperative and 24
hours postoperative) using RHI.
This study will also determine whether human albumin 5% reduces plasma biomarkers of
endothelial and glycocalyceal damage by measuring plasma concentrations of syndecan 1 and
endocan at baseline (before surgery), and 1 and 24 hours following surgery. Blood samples
will be taken on the morning of the surgery, within one hour of arrival to the intensive care
unit (ICU), and 24 hours after surgery or within 2 hours before discharge from the ICU (three
times altogether). These samples will be used to measure the plasma concentrations of two
biomarkers that measure endothelial injury.
volume replacement during cardiac surgery have improved postoperative endothelial function
compared to patients receiving 6% hydroxyethyl starch solutions. The postoperative
endothelial function, measured with peripheral arterial tonometry as reactive hyperemia index
(RHI) within 2 hours following surgery, will be compared in cardiac surgical patients
randomized to receive human albumin or 6% HES solutions for intraoperative volume
replacement. Within two hours of arrival to the ICU peripheral arterial tonometry using
EndoPAT will be performed. In a subset of 40 consecutive patients the investigators will
perform additional EndoPAT measurements to describe the expected changes that occur in
endothelial function during the perioperative period (baseline, early postoperative and 24
hours postoperative) using RHI.
This study will also determine whether human albumin 5% reduces plasma biomarkers of
endothelial and glycocalyceal damage by measuring plasma concentrations of syndecan 1 and
endocan at baseline (before surgery), and 1 and 24 hours following surgery. Blood samples
will be taken on the morning of the surgery, within one hour of arrival to the intensive care
unit (ICU), and 24 hours after surgery or within 2 hours before discharge from the ICU (three
times altogether). These samples will be used to measure the plasma concentrations of two
biomarkers that measure endothelial injury.
Cardiac surgical patients enrolled in the SHARP study will be randomized to 5% human albumin
or 6% HES on entrance to the operating room. Anesthetic and Surgical management will follow
protocol established by SHARP study including administration of a blinded study solution
which contains 5% human albumin or 6% HES following separation from cardiopulmonary bypass.
Blood will collected for measurement of baseline syndecan 1 and endocan following arterial
line and urinary catheter placement before surgical incision. At 1 and 24 hrs following
surgery completion, blood will be collected for measurement of syndecan 1 and endocan. Within
two hours of ICU arrival, assessment of endothelial function will be performed.
In a subset of patients (patients who consent for multiple measurements), assessment of
endothelial function will be performed preoperatively (baseline) and 24 hours after surgery.
Vasoactive substances may influence EndoPAT measurement. Thus the investigators will collect
data on use of preoperative antihypertensive medications that have direct or indirect effect
on arterial smooth muscle relaxation. Use of epinephrine, norepinephrine, vasopressin,
milrinone, nitroglycerine, nitroprusside, and sedatives such as propofol, dexmedetomidine and
others will be recorded and adjusted for in the analysis. Data on packed red blood cells
(PRBC) and blood component transfusion will be collected from Anesthesia Record Keeping
System. Indications for PRBC transfusion include hematocrit (HCT) <22% on cardiopulmonary
bypass and <24% off cardiopulmonary bypass, and hypovolemia with anemia (HCT<25% with mean
arterial blood pressure <60 mmHg or heart rate >100 bpm). Blood component transfusion
(platelets, fresh frozen plasma, cryoprecipitate) may be administered as necessary following
institutional standard of care. Imbalances in blood product transfusion between study groups
will be adjusted for in the analysis.
or 6% HES on entrance to the operating room. Anesthetic and Surgical management will follow
protocol established by SHARP study including administration of a blinded study solution
which contains 5% human albumin or 6% HES following separation from cardiopulmonary bypass.
Blood will collected for measurement of baseline syndecan 1 and endocan following arterial
line and urinary catheter placement before surgical incision. At 1 and 24 hrs following
surgery completion, blood will be collected for measurement of syndecan 1 and endocan. Within
two hours of ICU arrival, assessment of endothelial function will be performed.
In a subset of patients (patients who consent for multiple measurements), assessment of
endothelial function will be performed preoperatively (baseline) and 24 hours after surgery.
Vasoactive substances may influence EndoPAT measurement. Thus the investigators will collect
data on use of preoperative antihypertensive medications that have direct or indirect effect
on arterial smooth muscle relaxation. Use of epinephrine, norepinephrine, vasopressin,
milrinone, nitroglycerine, nitroprusside, and sedatives such as propofol, dexmedetomidine and
others will be recorded and adjusted for in the analysis. Data on packed red blood cells
(PRBC) and blood component transfusion will be collected from Anesthesia Record Keeping
System. Indications for PRBC transfusion include hematocrit (HCT) <22% on cardiopulmonary
bypass and <24% off cardiopulmonary bypass, and hypovolemia with anemia (HCT<25% with mean
arterial blood pressure <60 mmHg or heart rate >100 bpm). Blood component transfusion
(platelets, fresh frozen plasma, cryoprecipitate) may be administered as necessary following
institutional standard of care. Imbalances in blood product transfusion between study groups
will be adjusted for in the analysis.
Inclusion Criteria:
- Age 40 - 85 years old
- Scheduled for elective aortic valve replacement with or without coronary artery bypass
grafting with or without additional minor surgical procedure.
- Written, informed consent for participation in this investigation.
Exclusion Criteria:
- Patients with Raynaud's disease or other disease associated with upper extremity
vascular insufficiency,
- Inability to perform EndoPAT exam (inability to lie still for 15 min, or significant
finger deformity),
- Patients with renal failure with oliguria or anuria not related to hypovolemia.
- Patients receiving dialysis.
- Patients with preoperative renal insufficiency (Creatinine > 1.6 mg/dL)
- Anticipated deep hypothermic circulatory arrest
- Known hypersensitivity or allergy to hydroxyethyl starch or the excipients of
hydroxyethyl starch
- Clinical conditions with volume overload (e.g., patients in pulmonary edema or
congestive heart failure)
- Patients with severe hypernatremia or severe hyperchloremia
- Patients with intracranial bleeding
- Pregnant or breast feeding women
- Critically ill adult patients, including patients with sepsis, due to increased risk
of mortality and renal replacement therapy, (e.g. patients who are hospitalized in the
intensive care unit prior to surgery)
- Severe liver disease
- Pre-existing coagulation or bleeding disorders
- Any contraindications to proposed interventions.
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