Goal-directed Therapy in High-risk Surgery
Primary Purpose
Perioperative/Postoperative Complications, Hypovolemia, Hypoxia
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Protocol group 2
Protocol group 1
Sponsored by
About this trial
This is an interventional treatment trial for Perioperative/Postoperative Complications focused on measuring perioperative fluid optimization, goal-directed therapy, elderly, high-risk surgery
Eligibility 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.
Sites / Locations
- Guangzhou First Municipal People's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Protocol group 1
Protocol group 2
Arm Description
Using standard hemodynamic therapy
Using goal-directed therapy
Outcomes
Primary Outcome Measures
length of postoperative hospital stay
days from end of surgery to hospital discharge.
Secondary Outcome Measures
postoperative complications and mortality
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
mortality
Full Information
NCT ID
NCT01681238
First Posted
September 5, 2012
Last Updated
September 5, 2012
Sponsor
Guangzhou First People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01681238
Brief Title
Goal-directed Therapy in High-risk Surgery
Official Title
A Randomized Study of Goal-directed Therapy in the Elderly High-risk Patients Undergoing Total Hip Replacement
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Unknown status
Study Start Date
September 2012 (undefined)
Primary Completion Date
June 2013 (Anticipated)
Study Completion Date
June 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangzhou First People's Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 .
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perioperative/Postoperative Complications, Hypovolemia, Hypoxia
Keywords
perioperative fluid optimization, goal-directed therapy, elderly, high-risk surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Protocol group 1
Arm Type
Other
Arm Description
Using standard hemodynamic therapy
Arm Title
Protocol group 2
Arm Type
Experimental
Arm Description
Using goal-directed therapy
Intervention Type
Procedure
Intervention Name(s)
Protocol group 2
Other Intervention Name(s)
goal-directed therapy
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Protocol group 1
Other Intervention Name(s)
conventional fluid management
Intervention Description
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
Primary Outcome Measure Information:
Title
length of postoperative hospital stay
Description
days from end of surgery to hospital discharge.
Time Frame
28 days
Secondary Outcome Measure Information:
Title
postoperative complications and mortality
Description
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
mortality
Time Frame
28 days
Other Pre-specified Outcome Measures:
Title
information of hemodynamic and ScvO2 ,types and volumes of all fluids administered
Time Frame
24 hours after operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiangcai Ruan, MD, PHD
Organizational Affiliation
Guangzhou First Municipal People's Hospital,Guangzhou Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guangzhou First Municipal People's Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510180
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
12357146
Citation
Gan TJ, Soppitt A, Maroof M, el-Moalem H, Robertson KM, Moretti E, Dwane P, Glass PS. Goal-directed intraoperative fluid administration reduces length of hospital stay after major surgery. Anesthesiology. 2002 Oct;97(4):820-6. doi: 10.1097/00000542-200210000-00012.
Results Reference
background
PubMed Identifier
18292432
Citation
Mayer J, Boldt J, Wolf MW, Lang J, Suttner S. Cardiac output derived from arterial pressure waveform analysis in patients undergoing cardiac surgery: validity of a second generation device. Anesth Analg. 2008 Mar;106(3):867-72, table of contents. doi: 10.1213/ane.0b013e318161964d.
Results Reference
background
PubMed Identifier
21624138
Citation
Cecconi M, Fasano N, Langiano N, Divella M, Costa MG, Rhodes A, Della Rocca G. Goal-directed haemodynamic therapy during elective total hip arthroplasty under regional anaesthesia. Crit Care. 2011;15(3):R132. doi: 10.1186/cc10246. Epub 2011 May 30.
Results Reference
background
PubMed Identifier
19863764
Citation
Lees N, Hamilton M, Rhodes A. Clinical review: Goal-directed therapy in high risk surgical patients. Crit Care. 2009;13(5):231. doi: 10.1186/cc8039. Epub 2009 Oct 26.
Results Reference
background
PubMed Identifier
19546804
Citation
Moore JM. Continuous spinal anesthesia. Am J Ther. 2009 Jul-Aug;16(4):289-94. doi: 10.1097/MJT.0b013e3181729d2a.
Results Reference
background
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Goal-directed Therapy in High-risk Surgery
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