The Effect of Intraoperative Goal Directed Restricted Fluid Therapy on Extravascular Lung Water

NCT02845310 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2017-07-19

No results posted yet for this study

Summary

The aim of this study is to compare the use of Goal Directed fluid therapy guided by Stroke volume variation plus a restricted fluid management approach to standard fluid management in patients undergoing major abdominal operations.

Conditions

  • Surgery

Interventions

PROCEDURE

Restricted fluid therapy group

Patients will receive restricted fluid management (2ml/Kg/h) with concomitant SVV monitoring using ICON cardiometry device. GDT protocol will be used to fulfil the two targets (SVV \< 10% - MAP \>65 mmHg). A fluid bolus of 200 ml Lactated ringer will be infused if SVV is more than 10% for 5 minutes, the dose will be repeated every 10 minutes if SVV is still above 10%. If the total fluid boluses reached 20 ml/Kg in a patient with MAP \> 65 mmHg, no fluid boluses will be infused unless there is evident blood loss or hypotension. If MAP was achieved (\>65mmHg) at any time, the first three steps in the protocol will be bypassed. If MAP was not achieved after reaching 20 ml/Kg , norepinephrine (inotropes) will be given as shown in fig. 1 with dose of 0.01ug/kg/min.

PROCEDURE

Standard fluid management

Patients will receive standard fluid management of 6 ml/Kg/h plus rescue fluid boluses of 200 ml lactated ringer if Mean arterial pressure (MAP) decreased less than 65 mmHg and central venous pressure less than 8 mmH2o.

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Ahmed Mukhtar, Professor · Head of research committee section in anesthesia department

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2017-06-30
Completion
2017-06-30

Countries

  • Egypt

Study Locations

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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 NCT02845310 on ClinicalTrials.gov