Endothelial Function After Cardiac Surgery
Paraules clau
Resum
Descripció
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.
Dates
| Darrera verificació: | 06/30/2020 |
| Primer enviat: | 08/16/2016 |
| Inscripció estimada enviada: | 08/25/2016 |
| Publicat per primera vegada: | 08/28/2016 |
| Última actualització enviada: | 07/19/2020 |
| Publicació de l'última actualització: | 07/20/2020 |
| Data d'inici de l'estudi real: | 05/31/2016 |
| Data estimada de finalització primària: | 02/19/2020 |
| Data estimada de finalització de l’estudi: | 02/19/2020 |
Condició o malaltia
Intervenció / tractament
Drug: Human albumin
Drug: Hydroxyethyl starch
Fase
Grups de braços
| Braç | Intervenció / tractament |
|---|---|
| Other: Human albumin Human albumin 5% during surgery. | Drug: Human albumin human albumin 5% during surgery |
| Other: Hydroxyethyl starch Hydroxyethyl starch 6% (130/0.4) solution during surgery | Drug: Hydroxyethyl starch 6% Hydroxyethyl starch 130/0.4 during surgery |
Criteris d'elegibilitat
| Edats elegibles per estudiar | 40 Years Per a 40 Years |
| Sexes elegibles per estudiar | All |
| Accepta voluntaris saludables | Sí |
| Criteris | 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. |
Resultat
Mesures de resultats primaris
1. Reactive hyperemia index (RHI) [2 hours after surgery]
Mesures de resultats secundaris
1. Plasma concentrations of syndecan 1 [1 hours following surgery.]
2. Plasma concentrations of syndecan 1 [24 hours following surgery.]
3. Plasma concentrations of endocan [1 following surgery.]
4. Plasma concentrations of endocan [24 hours following surgery.]
