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CompletedNCT03955237Updated May 20, 2019

Perioperative Fluid Management According to the Preoperative and Perioperative Glucose Level

An interventional study of Drug: dextrose containing infusion in Perioperative Complication, sponsored by Istanbul University. Completed. Open to participants aged 6 Months to 12 Years. Per ClinicalTrials.gov, last updated 2019-05-20.

Sponsored by Istanbul University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
250
Allocation
Randomized
Ages
6 Months to 12 Years
Sex
All
01

Study summary

Background:Hyperglycemia and hypoglycemia both cause detrimental side effects for pediatric patients. Prolonged fasting time, age dependent physiological diffences and individual differences of patients make complicated the perioperative fluid therapy. Isotonic electrolyte solutions without glucose or with lower glucose concentrations recommended for intraoperative period in pediatric patients.

Objective: The aim of this prospective study is to evaluate the different glucose concentrations(without dextrose, 1 % dextrose+LR, 2 % dextrose+LR) in perioperative infusion solutions according to preoperative blood glucose level to maintain normoglycemia in pediatric patients.

Method: The consecutive 250 eligible pediatric patients aged between 6 months- 12 years with ASA risk score of I-II undergoing surgery lasting less than four hours were enrolled the study in six months period. Patient demographics, procedure, preoperative fasting time, preoperative and postoperative glucose levels were documented. Lactate ringer (LR) solution with % 2 glucose was infused to the patients with preoperative blood glucose level lower than 60 mg/dL, LR solution with % 1 glucose was used for the patients with preoperative blood glucose level between 60-90 mg/dL, LR solution without glucose was used for the patients with preoperative blood glucose level higher than 90 mg/dL.

Read the detailed description

Lactate ringer (LR) solution with % 2 glucose was infused to the patients with preoperative blood glucose level lower than 60 mg/dL, LR solution with % 1 glucose was used for the patients with preoperative blood glucose level between 60-90 mg/dL, LR solution without glucose was used for the patients with preoperative blood glucose level higher than 90 mg/dL

02

Conditions studied

  • Perioperative Complication
03

In context

Lead sponsor

Istanbul University is the lead sponsor of 496 studies on the registry; 79 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

İnclusion criteria;

  • 6 months- 12 years old, ASA I-II children
  • Undergoing surgery lasting less than four hours were enrolled the study

Exclusion Criteria:

  • Diabetes mellitus
  • Parenteral nutrition or enteral nutrition
  • Patient with metabolic disorders,
  • ASA III-IV patients
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
250 participants (actual)

Study arms

  • Active comparator
    non glucose infusion group

    Drug: LR infusion LR solution without glucose; the patients with preoperative blood glucose level higher than 90 mg/dL.

    Procedure: Drug: dextrose containing infusion

  • Active comparator
    Drug:1% Dextrose infusion group

    Drug:LR+ 1% Dextrose infusion LR solution with % 1 glucose: the patients with preoperative blood glucose level between 60-90 mg/dL,

    Procedure: Drug: dextrose containing infusion

  • Active comparator
    2% Dextrose infusion group

    Drug:LR+ 2 % Dextrose infusion Lactate ringer (LR) solution with % 2 glucose; the patients with preoperative blood glucose level lower than 60 mg/dL,

    Procedure: Drug: dextrose containing infusion

Interventions

  • ProcedureDrug: dextrose containing infusion

    Drug: infusing dextrose containing or non glucose fluid according to blood glucose level

    Also known as: drug: non dextrose containing infusion

06

What researchers measure

Primary outcomes

  1. glucose level

    blood glucose level measurement with finger stick monitoring

    Time frame: perioperative period

Secondary outcomes

  1. hyperglysemia or hypoglysemia ratio

    blood glucose level measurement with finger stick monitoring

    Time frame: perioperative

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 20, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03955237
Lead sponsor
Istanbul University
Responsible party
Ayse Cigdem Tutuncu (Assoc Prof, Istanbul University) — Principal investigator
First posted
May 20, 2019
Start date
Jan 2015
Primary completion
Apr 2015
Completion
Jul 2016
Last update
May 20, 2019
View the source record on ClinicalTrials.gov ↗

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