Perioperative Fluid Management According to the Preoperative and Perioperative Glucose Level

Perioperative Fluid Management According to the Preoperative and Perioperative Glucose

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.

Study Overview

• Status: Completed
• Conditions: Perioperative Complication
• Intervention / Treatment: Procedure: Drug: dextrose containing infusion

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

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 12 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Drug: infusing dextrose containing or non glucose fluid according to blood glucose level; Other Names: drug: non 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; Drug: infusing dextrose containing or non glucose fluid according to blood glucose level; Other Names: drug: non 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; Drug: infusing dextrose containing or non glucose fluid according to blood glucose level; Other Names: drug: non dextrose containing infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
glucose level	blood glucose level measurement with finger stick monitoring	perioperative period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hyperglysemia or hypoglysemia ratio	blood glucose level measurement with finger stick monitoring	perioperative

Collaborators and Investigators

• Sponsor: Istanbul University

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (ACTUAL): April 1, 2015
• Study Completion (ACTUAL): July 1, 2016

Study Registration Dates

• First Submitted: August 20, 2017
• First Submitted That Met QC Criteria: May 16, 2019
• First Posted (ACTUAL): May 20, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 20, 2019
• Last Update Submitted That Met QC Criteria: May 16, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 82546