Supernormal Goal for Proximal Femur Fracture
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|ClinicalTrials.gov Identifier: NCT02194101|
Recruitment Status : Unknown
Verified July 2014 by Xiangcai Ruan, Guangzhou First People's Hospital.
Recruitment status was: Not yet recruiting
First Posted : July 18, 2014
Last Update Posted : July 18, 2014
|Condition or disease||Intervention/treatment|
|Femoral Fractures||Procedure: Supernormal oxygen delivery goal therapy|
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|Official Title:||Supernormal Oxygen Delivery May Not be a Valid Goal for Patients With Proximal Femur Fracture. An Observational Pilot Study|
|Study Start Date :||August 2014|
|Estimated Primary Completion Date :||April 2015|
|Estimated Study Completion Date :||June 2015|
Supernormal oxygen delivery goal therapy
Patients will be aged over 70 yr and weight over 35 kg, and undergoing proximal femur fracture (PFF) surgery under peripheral nerve block and laryngeal mask airway anesthesia.
Procedure: Supernormal oxygen delivery goal therapy
A 10% increase in stroke volume (SV) after fluid challenge (5 ml/kg) with Ringer's lactate solution will be deemed positive. Oxygen delivery will be check when fluid challenge becomes negative. If oxygen delivery index (DO2I) can not be greater than 600 mL/m2, then dobutamine will be started at a dose of 2.5 μg/kg/min and increased by the same increment every 20 minutes until the described target is reached or until a maximal dose of 10 μg/kg/min is given. Dobutamine is decreased in dose or discontinued if the heart rate is above 100 beats per minute or shows signs of cardiac ischemia. Blood transfusions will be used to maintain a hemoglobin concentration over 8mg/dL.
- Oxgen delivery index [ Time Frame: At the end of 4 hour goal-directed therapy ]To attain a improved oxygen delivery index at the end of 4 hour goal-directed therapy
- Hear rate augmentation [ Time Frame: Day 1 ]
- Hemodynamic response [ Time Frame: Day 1 ]Including stroke volume, cardiac index, base excess, lactate, hemoglobin, and urine output.
- fluid volume administrated [ Time Frame: intraoperatively ]
- Length of hospital stay [ Time Frame: Day 30 ]
- Postoperative morbidity [ Time Frame: day 5 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02194101
|Contact: Xiangcai Ruan, MD, PhDfirstname.lastname@example.org|
|Contact: Jingwen Guo|
|Guangzhou First Municipal People's Hospital|
|Guangzhou, Guangdong, China, 510180|
|Principal Investigator:||Xiangcai Ruan, MD., PhD.||Guangzhou First Municipal People's Hospital,Guangzhou,Guangdong,China,510180|