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

NCT02845310 | Completed DMC

• 1 other identifier: N-16-2016
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Extravascular lung water (Lung ultrasound score)

  Lung ultrasound with a 5-MHz curved array probe (MindrayDC-N6; Mindray; Shenzhen, China). Lung ultrasound will be assessed for the presence of B lines. The B line is the name given to an artifact with seven features: a hydroaeric comet-tail artifact; arising from the pleural line; hyperechoic; well defined; spreading up indefinitely; erasing A lines; and moving with lung sliding when lung sliding is present. The lung ultrasound score was obtained by scanning 12-rib interspaces with the probe longitudinally applied perpendicular to the wall. Each hemi-thorax was divided in six areas: two anterior areas, two lateral areas, and two posterior areas. The sum of B-lines found on each scanning site (0: absence; 1: B7 lines: multiple B-lines 7 mm apart; 2: B3 lines: multiple B 3 mm apart; 3: consolidation) yields a score from 0 to 36.

  Lung ultrasound will be performed in the postoperative care unit 30 minutes after patient recovery

Secondary Outcomes (1)

• Intraoperative fluid requirement

  intraoperatively

Study Arms (2)

Restricted fluid therapy group

EXPERIMENTAL

Patients will receive restricted fluid management guided by concomitant SVV monitoring. GDT protocol

Procedure: Restricted fluid therapy group

Control group

PLACEBO COMPARATOR

Patients will receive standard fluid management.

Procedure: Standard fluid management

Interventions

Restricted fluid therapy group PROCEDURE

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.

Restricted fluid therapy group

Standard fluid management PROCEDURE

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.

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for major abdominal operations

You may not qualify if:

• Patients with arrhythmias, pulmonary hypertension or impaired cardiac contractility.
• Patients with impaired liver or kidney function.
• Patients with BMI above 40.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Egypt

Location

Study Officials

• Ahmed Mukhtar, Professor

  Head of research committee section in anesthesia department

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesia and critical care medicine

Study Record Dates

• First Submitted: July 21, 2016
• First Posted: July 27, 2016
• Study Start: September 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: July 19, 2017

Record last verified: 2017-07

Locations

EG (1)