Ignite Creation Date:
2024-05-06 @ 8:50 AM
Last Modification Date:
2024-10-26 @ 12:05 PM
Study NCT ID:
NCT02831270
Status:
COMPLETED
Last Update Posted:
2016-07-13
First Post:
2016-07-10
Brief Title:
Acute Normovolemic Hemodilution on Serum-creatinine Concentration in Cardiac Surgery
Sponsor:
Konkuk University Medical Center
Organization:
Konkuk University Medical Center
Study Overview
Official Title:
Does Acute Normovolemic Hemodilution Affect Intraoperative Value of Serum-creatinine Concentration in Patients Undergoing Cardiac Surgery
Status:
COMPLETED
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Serum-creatinine level s-Cr is an important factor for predicting perioperative patients outcome regarding acute kidney injury Although cardiopulmonary bypass CPB an essential procedure for cardiac surgery dilutes patients blood components possible impact of applying acute normovolemic hemodilution ANH and CPB on s-Cr has not been well investigated
In patients undergoing cardiac surgery employing moderate hypothermic CPB age 20-71 years n32 ANH will be randomly applied to 15 patients Group-ANH but not in 17 patients Group-C before initiating CPB For ANH procedure consisting of 5 mlkg of blood salvage and administering 5 mlkg of balanced hydroxyethyl starch HES 13004 for 15 min will be started at 30 min after anesthesia induction and before CPB application for surgery In both groups moderate hypothermic CPB will be initiated by using 1600-1800 ml of bloodless priming solution The changes of hematocrit Hct Na K HCO3- Ca2 osmolarity s-Cr will be determined before ANH T1 after the first ANH of 25 mlkg T2 and after the second ANH of 25 mlkg T3 30 sec and 60 sec after the initiation of CPB T4 T5 immediately and 1 hour after the weaning from CPB T6 T7 and at the end of surgery T8 S-Cr will be determined by using a point-of-care test device StatSensor Creatinine Nova Biomedical USA
In patients undergoing cardiac surgery employing moderate hypothermic CPB age 20-71 years n32 ANH will be randomly applied to 15 patients Group-ANH but not in 17 patients Group-C before initiating CPB For ANH procedure consisting of 5 mlkg of blood salvage and administering 5 mlkg of balanced hydroxyethyl starch HES 13004 for 15 min will be started at 30 min after anesthesia induction and before CPB application for surgery In both groups moderate hypothermic CPB will be initiated by using 1600-1800 ml of bloodless priming solution The changes of hematocrit Hct Na K HCO3- Ca2 osmolarity s-Cr will be determined before ANH T1 after the first ANH of 25 mlkg T2 and after the second ANH of 25 mlkg T3 30 sec and 60 sec after the initiation of CPB T4 T5 immediately and 1 hour after the weaning from CPB T6 T7 and at the end of surgery T8 S-Cr will be determined by using a point-of-care test device StatSensor Creatinine Nova Biomedical USA
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None