Goal-directed Therapy in High-risk Surgery

NCT01681238 | Unknown DMC

• 1 other identifier: GZZD-025
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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 .

Conditions

Perioperative/Postoperative Complications; Hypovolemia; Hypoxia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• length of postoperative hospital stay

  days from end of surgery to hospital discharge.

  28 days

Secondary Outcomes (1)

• postoperative complications and mortality

  28 days

Other Outcomes (1)

• information of hemodynamic and ScvO2 ,types and volumes of all fluids administered

  24 hours after operation

Study Arms (2)

Protocol group 1

OTHER

Using standard hemodynamic therapy

Procedure: Protocol group 1

Protocol group 2

EXPERIMENTAL

Using goal-directed therapy

Procedure: Protocol group 2

Interventions

Protocol group 2 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

Also known as: goal-directed therapy

Protocol group 2

Protocol group 1 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

Also known as: conventional fluid management

Protocol group 1

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Guangzhou First People's Hospital: lead

Study Sites (1)

Guangzhou First Municipal People's Hospital

Guangzhou, Guangdong, 510180, China

Location

Related Publications (5)

• 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.

  PMID: 12357146 BACKGROUND

• 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.

  PMID: 18292432 BACKGROUND

• 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.

  PMID: 21624138 BACKGROUND

• 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.

  PMID: 19863764 BACKGROUND

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

  PMID: 19546804 BACKGROUND

MeSH Terms

Conditions

Postoperative Complications; Hypovolemia; Hypoxia

Interventions

Early Goal-Directed Therapy

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Critical Care; Patient Care; Therapeutics

Study Officials

• Xiangcai Ruan, MD, PHD

  Guangzhou First Municipal People's Hospital,Guangzhou Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Vice Chair

Study Record Dates

• First Submitted: September 5, 2012
• First Posted: September 7, 2012
• Study Start: September 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: September 7, 2012

Record last verified: 2012-09

Locations

CN (1)