Goal-directed Therapy in High-risk Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01681238|
Recruitment Status : Unknown
Verified September 2012 by Xiangcai Ruan, Guangzhou First Municipal People's Hospital.
Recruitment status was: Active, not recruiting
First Posted : September 7, 2012
Last Update Posted : September 7, 2012
|Condition or disease||Intervention/treatment|
|Perioperative/Postoperative Complications Hypovolemia Hypoxia||Procedure: Protocol group 2 Procedure: Protocol group 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||72 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized Study of Goal-directed Therapy in the Elderly High-risk Patients Undergoing Total Hip Replacement|
|Study Start Date :||September 2012|
|Estimated Primary Completion Date :||June 2013|
|Estimated Study Completion Date :||June 2013|
Protocol group 1
Using standard hemodynamic therapy
Procedure: Protocol group 1
The goal of this protocol is to ensure MAP> 65 mmHg, CVP 8-12 cmH2O. If meet the above requirements, do nothing, re-evaluate after 5min. If CVP <8 cmH2O, the patient will receive an additional 200ml colloid .If MAP beyond the scope of 65-100 mmHg, vasoactive agents will be administrated until achieve the goal. If 25mL/kg colloid given before goal is achieved, fluid challenges will then be performed with 200mL boluses of Ringer's lactate solution. Blood transfusions will be used to maintain a hemoglobin concentration over 8mg/dL
Other Name: conventional fluid management
Experimental: Protocol group 2
Using goal-directed therapy
Procedure: Protocol group 2
ensure SpO2≥ 92%, MAP 65-100 mmHg, HR <100 bpm, Hb> 8mg/dL and temperature ≥ 36℃, the patients were then administrated a 200 ml colloid as a fluid challenge. The fluid challenge repeat until the SV failed to increase by a factor of 10%. If at this stage the 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 20 μg/kg/min is given. Dobutamine is decreased in dose or discontinued if the heart rate is above 120 beats per minute or shows signs of cardiac ischemia. Blood transfusions will be used to maintain a hemoglobin concentration over 8mg/dL
Other Name: goal-directed therapy
- length of postoperative hospital stay [ Time Frame: 28 days ]days from end of surgery to hospital discharge.
- postoperative complications and mortality [ Time Frame: 28 days ]
- Major complications: Infection , Major cardiovascular complications , Pulmonary Embolism, Renal Failure, Anaemia requiring blood transfusion in the presence of shock.
- Minor complications: Hypotension (systolic blood pressure < 90 mmHg) requiring fluid boluses, Uncomplicated infections (not requiring intra-venous antibiotic therapy and with no signs of sepsis, i.e. uncomplicated urinary tract infections), Anemia requiring blood transfusions in the absence of shock.
- PONV: Postoperative Nausea and Vomiting
- delirium and postoperative cognitive dysfunction
- information of hemodynamic and ScvO2 ,types and volumes of all fluids administered [ Time Frame: 24 hours after operation ]
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): NCT01681238
|Guangzhou First Municipal People's Hospital|
|Guangzhou, Guangdong, China, 510180|
|Principal Investigator:||Xiangcai Ruan, MD, PHD||Guangzhou First Municipal People's Hospital,Guangzhou Medical College|