Goal-directed Therapy in High-risk Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Guangzhou First Municipal People’s Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Xiangcai Ruan, Guangzhou First Municipal People's Hospital
ClinicalTrials.gov Identifier:
NCT01681238
First received: September 5, 2012
Last updated: NA
Last verified: September 2012
History: No changes posted
  Purpose

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 Intervention
Perioperative/Postoperative Complications
Hypovolemia
Hypoxia
Procedure: Protocol group 2
Procedure: Protocol group 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Guangzhou First Municipal People’s Hospital:

Primary Outcome Measures:
  • length of postoperative hospital stay [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    days from end of surgery to hospital discharge.


Secondary Outcome Measures:
  • postoperative complications and mortality [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    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:
  • information of hemodynamic and ScvO2 ,types and volumes of all fluids administered [ Time Frame: 24 hours after operation ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 72
Study Start Date: September 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01681238

Locations
China, Guangdong
Guangzhou First Municipal People's Hospital
Guangzhou, Guangdong, China, 510180
Sponsors and Collaborators
Guangzhou First Municipal People’s Hospital
Investigators
Principal Investigator: Xiangcai Ruan, MD, PHD Guangzhou First Municipal People's Hospital,Guangzhou Medical College
  More Information

Publications:
Responsible Party: Xiangcai Ruan, Professor, Vice Chair, Guangzhou First Municipal People's Hospital
ClinicalTrials.gov Identifier: NCT01681238     History of Changes
Other Study ID Numbers: GZZD-025
Study First Received: September 5, 2012
Last Updated: September 5, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Guangzhou First Municipal People’s Hospital:
perioperative fluid optimization
goal-directed therapy
elderly
high-risk surgery

Additional relevant MeSH terms:
Hypovolemia
Postoperative Complications
Pathologic Processes

ClinicalTrials.gov processed this record on October 20, 2014