Perioperative Fluid Management According to the Preoperative and Perioperative Glucose Level

NCT03955237 | Completed

• 1 other identifier: 82546
• Study Type: interventional
• Target: 250
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Perioperative Complication

Outcome Measures

Primary Outcomes (1)

• glucose level

  blood glucose level measurement with finger stick monitoring

  perioperative period

Secondary Outcomes (1)

• hyperglysemia or hypoglysemia ratio

  perioperative

Study Arms (3)

non glucose infusion group

ACTIVE COMPARATOR

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:1% Dextrose infusion group

ACTIVE COMPARATOR

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

2% Dextrose infusion group

ACTIVE COMPARATOR

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

Drug: dextrose containing infusion PROCEDURE

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

Also known as: drug: non dextrose containing infusion

2% Dextrose infusion group; Drug:1% Dextrose infusion group; non glucose infusion group

Eligibility Criteria

• Age: 6 Months - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may not qualify if:

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

Sponsors & Collaborators

• Istanbul University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Prof

Model Details: 3 different type of fluid

Study Record Dates

• First Submitted: August 20, 2017
• First Posted: May 20, 2019
• Study Start: January 1, 2015
• Primary Completion: April 1, 2015
• Study Completion: July 1, 2016
• Last Updated: May 20, 2019

Record last verified: 2019-05