Goal-directed Therapy in High-risk Surgery

NCT ID: NCT01681238

Last Updated: 2012-09-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2013-06-30

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.

Conditions

Perioperative/Postoperative Complications; Hypovolemia; Hypoxia

Keywords

perioperative fluid optimization; goal-directed therapy; elderly; high-risk surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Protocol group 1

Using standard hemodynamic therapy

Group Type: OTHER

Protocol group 1

Intervention Type: PROCEDURE

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

Protocol group 2

Using goal-directed therapy

Group Type: EXPERIMENTAL

Protocol group 2

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: 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

Intervention Type: PROCEDURE

Other Intervention Names

goal-directed therapy; conventional fluid management

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.

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangzhou First People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xiangcai Ruan

Professor, Vice Chair

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiangcai Ruan, MD, PHD

Role: PRINCIPAL_INVESTIGATOR

Guangzhou First Municipal People's Hospital,Guangzhou Medical College

Locations

Guangzhou First Municipal People's Hospital

Guangzhou, Guangdong, China

Countries

China

References

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.

Reference Type: BACKGROUND

PMID: 12357146 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18292432 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21624138 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19863764 (View on PubMed)

Moore JM. Continuous spinal anesthesia. Am J Ther. 2009 Jul-Aug;16(4):289-94. doi: 10.1097/MJT.0b013e3181729d2a.

Reference Type: BACKGROUND

PMID: 19546804 (View on PubMed)

Other Identifiers

GZZD-025

Identifier Type: -

Identifier Source: org_study_id