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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. Identifier: NCT01681238
Recruitment Status : Unknown
Verified September 2012 by Xiangcai Ruan, Guangzhou First People's Hospital.
Recruitment status was:  Active, not recruiting
First Posted : September 7, 2012
Last Update Posted : September 7, 2012
Information provided by (Responsible Party):
Xiangcai Ruan, Guangzhou First People's Hospital

Brief Summary:
There is growing evidence that the risk of postoperative complications can be decreased by optimizing the amount and type of infusion fluids given during surgery, steered by goal-directed therapy based on flow-related hemodynamic parameters, particularly in high-risk patients. This study is undertaken subsequently to test the hypothesis that the intraoperative goal-directed strategy based on FloTrac/Vigileo, a minimally invasive monitor, can partially prevented postoperative complications and shorten hospital stay in the elderly high-risk patients undergoing total hip replacement with continuous spinal anaesthesia .

Condition or disease Intervention/treatment Phase
Perioperative/Postoperative Complications Hypovolemia Hypoxia Procedure: Protocol group 2 Procedure: Protocol group 1 Not Applicable

Detailed Description:
After sedated with IV 0.02 mg/kg midazolam, all patients will receive arterial, central venous, and L3-4 intrathecal catheterizations. A T12 sensory level block was attained with ropivacaine through the intrathecal catheter. Besides currently recommended monitoring during the intraoperative period, arterial blood pressure, stroke volume (Edwards Lifesciences, Irvine, Calif.), and central venous oxygen saturation (Edwards Lifesciences) will be measured and recorded. All Patients will receive intranasal oxygen 2 mL/min and be kept normothermic (body temperature > 36°C). Patients in both groups receive 8 mL/kg/hour of Ringer's lactate solution from 30 minutes prior to induction of anaesthesia through the end of surgery, when the rate will be decreased to 100 mL/hour. In addition, boluses of colloid will be given to different protocol group according to the study arm to which the patient allocated.Postoperative care and discharge criteria were predefined using the hospital care map and protocol.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. length of postoperative hospital stay [ Time Frame: 28 days ]
    days from end of surgery to hospital discharge.

Secondary Outcome Measures :
  1. postoperative complications and mortality [ Time Frame: 28 days ]
    1. Major complications: Infection , Major cardiovascular complications , Pulmonary Embolism, Renal Failure, Anaemia requiring blood transfusion in the presence of shock.
    2. 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.
    3. PONV: Postoperative Nausea and Vomiting
    4. delirium and postoperative cognitive dysfunction
    5. mortality

Other Outcome Measures:
  1. information of hemodynamic and ScvO2 ,types and volumes of all fluids administered [ Time Frame: 24 hours after operation ]

Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 1. Adult patients scheduled for total hip replacement at this institution.
  • 2. American Society of Anaesthesiologists (ASA) physical status of III or VI.
  • 3. Two or more risk factors according to risk index of Lee .

Exclusion Criteria:

  • 1. Age under 70years old
  • 2. idiopathic coagulopathy: with warfarin or heparin
  • 3. systemic or local infection
  • 4. unable to cooperate
  • 5. spinal trauma or severe low back pain history
  • 6. patient refusal.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01681238

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China, Guangdong
Guangzhou First Municipal People's Hospital
Guangzhou, Guangdong, China, 510180
Sponsors and Collaborators
Guangzhou First People's Hospital
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Principal Investigator: Xiangcai Ruan, MD, PHD Guangzhou First Municipal People's Hospital,Guangzhou Medical College
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Responsible Party: Xiangcai Ruan, Professor, Vice Chair, Guangzhou First People's Hospital Identifier: NCT01681238    
Other Study ID Numbers: GZZD-025
First Posted: September 7, 2012    Key Record Dates
Last Update Posted: September 7, 2012
Last Verified: September 2012
Keywords provided by Xiangcai Ruan, Guangzhou First People's Hospital:
perioperative fluid optimization
goal-directed therapy
high-risk surgery
Additional relevant MeSH terms:
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Postoperative Complications
Signs and Symptoms, Respiratory
Signs and Symptoms
Pathologic Processes