Does Acute Normovolemic Hemodilution Affect Intraoperative Value of Serum-creatinine Concentration in Patients Undergoing Cardiac Surgery?
Sponsor study identifier
observational
32
1 country
1
Study Start
December 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2016
Actual (reported)Study Completion
June 2016
Actual (reported)Serum-creatinine level (s-Cr) is an important factor for predicting perioperative patient's outcome regarding acute kidney injury. Although cardiopulmonary bypass (CPB), an essential procedure for cardiac surgery, dilutes patient's 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, n=32), 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 ml/kg of blood salvage and administering 5 ml/kg of balanced hydroxyethyl starch (HES) 130/0.4 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 2.5 ml/kg (T2), and after the second ANH of 2.5 ml/kg (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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2016
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2011
Date type not reportedThis date has not been verified as actual or estimated.
June 2016
Actual (reported)June 2016
Actual (reported)July 10, 2016
Actual (reported)July 13, 2016
Actual (reported)serum creatinine (s-Cr) concentration
before ANH
Patients undergoing cardiac surgery supposed not to get acute normovolemic hemodilution (ANH) before CPB
Patients undergoing cardiac surgery supposed to get aucte normovolemic hemodilution (ANH) before CPB
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients undergoing elective cardiac surgery due to valvular heart disease
Konkuk University Medical Center
Seoul, 143-729, South Korea
32 participants (actual enrollment reported by the registry).
First Submitted
July 10, 2016
First Posted
July 13, 2016
Study Start
December 2011
Date type not reportedThis date has not been verified as actual or estimated.
The Impact of Storage Techniques on Platelets Number and Function After Acute Normovolemic Hemodilution (ANH)
Contact the study team to confirm eligibility.
Primary Completion
June 2016
Actual (reported)Study Completion
June 2016
Actual (reported)Last Updated
July 13, 2016
Record last verified: 2016-07
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: