NCT01350076

Brief Summary

The objectives of this study are 1) to investigate the influence of different fluid regimen (Liberal regimen versus Goal directed therapy regimen) on postoperative outcome such as weight gain, delayed gut function recovery, pneumonia and 2) to ascertain the reliability of USCOM monitoring using serum lactate and base deficit as control parameters.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2011

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 9, 2011

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

May 9, 2011

Status Verified

May 1, 2011

Enrollment Period

1.7 years

First QC Date

March 30, 2011

Last Update Submit

May 6, 2011

Conditions

Adverse Anesthesia Outcome

Keywords

intraoperative fluidpediatricgoal directed therapypediatric with major abdominal surgeryASA less than or equal to 3Duration of surgery less than 2 hoursBody weight more than or equal to 15 kg

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients with 5% postoperative weight gain between control group and study group

    Body weight

    24 hours

Secondary Outcomes (2)

  • Postoperative morbidity

    4 days

  • Amount of intraoperative fluid

    1 day

Study Arms (2)

control group

ACTIVE COMPARATOR

Control group will receive conventional liberal fluid regimen with crystalloid Liberal fluid regimen = Maintenance fluid + fasting fluid + dehydration + third space loss Maintenance fluid = (4X BW 1-10 kg) + (2X1BW11-20 kg) + (1X BW 0ver 21 kg) Fasting fluid = maintenance fluid X fasting duration

Drug: conventional liberal fluid regimen

study group

EXPERIMENTAL

Study group will receive restricted fluid regimen (the same as control group except third space replacement) plus goal directed fluid therapy to maintain adequate CO guided by USCOM as shown in diagram (figure 1). Figure 1 goal directed fluid therapy SVV = Stroke volume variation SVI = Stroke volume index CI = Cardiac index

Drug: restricted fluid regimen

Interventions

conventional liberal fluid regimenDRUG

Control group will receive conventional liberal fluid regimen with crystalloid Liberal fluid regimen = Maintenance fluid + fasting fluid + dehydration + third space loss Maintenance fluid = (4X BW 1-10 kg) + (2X1BW11-20 kg) + (1X BW 0ver 21 kg) Fasting fluid = maintenance fluid X fasting duration

Also known as: crystalloid
control group
restricted fluid regimenDRUG

Study group will receive restricted fluid regimen (the same as control group except third space replacement) plus goal directed fluid therapy to maintain adequate CO guided by USCOM as shown in diagram (figure 1). Figure 1 goal directed fluid therapy SVV = Stroke volume variation SVI = Stroke volume index CI = Cardiac index

Also known as: crystalloid
study group

Eligibility Criteria

Age1 Minute - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Body weight \< 15 kg
  • Under going major abdominal surgery such as tumor removal, gut obstruction, pull through, etc. under general anesthesia and invasive arterial pressure monitoring if justified
  • ASA \< or = 3
  • Duration of surgery \> or = 2 hours

You may not qualify if:

  • Cardiopulmonary disease
  • Renal insufficiency
  • Intraoperative complications such as massive bleeding, severe hypotension, prolonged need for mandatory ventilation
  • reoperation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Siriraj Hospital

Bangkok, Bangkok, 10700, Thailand

Location

MeSH Terms

Interventions

Crystalloid Solutions

Intervention Hierarchy (Ancestors)

Isotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Suwannee Suraseranivongse, MD

    Mahidol University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Suwannee Suraseranivongse, MD

CONTACT

6681 4087655sisur@mahidol.ac.th

Suwannee Suraseranivongse

CONTACT

sisur2498@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 30, 2011

First Posted

May 9, 2011

Study Start

October 1, 2011

Primary Completion

June 1, 2013

Study Completion

September 1, 2013

Last Updated

May 9, 2011

Record last verified: 2011-05

Locations

TH(1)