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Goal-directed Therapy in High-risk Surgery

NCT01681238 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2012-09-07

No results posted yet for this study

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

Interventions

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

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

Sponsors & Collaborators

  • Guangzhou First People's Hospital

    lead OTHER

Principal Investigators

  • Xiangcai Ruan, MD, PHD · Guangzhou First Municipal People's Hospital,Guangzhou Medical College

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01681238 on ClinicalTrials.gov