Clinical trial NCT01681238: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Perioperative/Postoperative Complications
Hypovolemia
Hypoxia
Keywords: perioperative fluid optimization
goal-directed therapy
elderly
high-risk surgery
Lead sponsor: Guangzhou First People's Hospital
Sponsor class: OTHER
First posted: 2012-09-07
Enrollment: 72
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: length of postoperative hospital stay
timeFrame: 28 days
Secondary outcomes:
measure: postoperative complications and mortality
timeFrame: 28 days
Other outcomes:
measure: information of hemodynamic and ScvO2 ,types and volumes of all fluids administered
timeFrame: 24 hours after operation
Locations:
city: Guangzhou
country: China
facility: Guangzhou First Municipal People's Hospital
state: Guangdong
Study officials:
affiliation: Guangzhou First Municipal People's Hospital,Guangzhou Medical College
name: Xiangcai Ruan, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
citation: Moore JM. Continuous spinal anesthesia. Am J Ther. 2009 Jul-Aug;16(4):289-94. doi: 10.1097/MJT.0b013e3181729d2a.