Perioperative Fluid Management According to the Preoperative and Perioperative Glucose Level

NCT ID: NCT03955237

Last Updated: 2019-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2016-07-31

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.

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

Conditions

Perioperative Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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,

Group Type: ACTIVE_COMPARATOR

Drug: dextrose containing infusion

Intervention Type: PROCEDURE

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

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,

Group Type: ACTIVE_COMPARATOR

Drug: dextrose containing infusion

Intervention Type: PROCEDURE

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

non glucose infusion group

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

Group Type: ACTIVE_COMPARATOR

Drug: dextrose containing infusion

Intervention Type: PROCEDURE

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

Interventions

Drug: dextrose containing infusion

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

Intervention Type: PROCEDURE

Other Intervention Names

drug: non dextrose containing infusion

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul University

OTHER

Sponsor Role: lead

Responsible Party

Ayse Cigdem Tutuncu

Assoc Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

82546

Identifier Type: -

Identifier Source: org_study_id