RecruitingACTRN12619000833167

An investigation of intraoperative maintenance fluid containing glucose 10 mg/ml to infants (1-12 moths old).

A safety and physiology-study of a near isotonic maintenance fluid containing 1 % glucose to infants (1-12 months old)


Sponsor

Department of Paediatric Perioperative Medicine and Intensive Care, Karolinska University Hospital

Enrollment

375 participants

Start Date

Sep 16, 2019

Study Type

Interventional

Conditions

Summary

European guidelines for intraoperative maintenance fluid recommend a near-isotonic solution containing 1-2.5 % glucose. In most European countries, a near-isotonic solution containing 2,5 % glucose is not available. This necessitates anesthetic personal to add extra sodium to the solution. This may be hazardous – risk of adding wrong electrolyte, risk of infection etc. On the other hand, a commercial near-isotonic 1 % glucose solution is available. However, there are limited safety data for the risk of developing hypoglycemia for infants when 1 % glucose are given intraoperatively. Furthermore, basic knowledge of intraoperatively glucose metabolism are lacking. This study will considerably strengthen safety data for using a 1 % glucose solution. In addition, the study will provide new information of intraoperative endogenous glucose production, energy production and importance of duration of fasting for glucose metabolism intraoperatively.


Eligibility

Sex: Both males and femalesMin Age: 1 MonthsMax Age: 12 Monthss

Inclusion Criteria1

  • Infants undergoing surgery at Karolinska University Hospital, Stockholm Sweden.

Exclusion Criteria1

  • Metabolic and/or endocrinology disease, liver disease affecting liver function, malnutrition, small for gestational age at birth (>2 standard deviations), ongoing medication with beta-blocker, preoperatively parenteral nutrition, preoperative glucose infusion of > 6 hours, plasma glucose concentration < 3.0 mmol/L at induction of anesthesia.

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Interventions

The main objective of this observational study is to investigate if normoglycemia is maintained when a near isotonic maintenance fluid containing 1 % glucose is given intraoperatively to infants (1-12

The main objective of this observational study is to investigate if normoglycemia is maintained when a near isotonic maintenance fluid containing 1 % glucose is given intraoperatively to infants (1-12 moths of age). (n=375). The administered 1% glucose near-isotonic maintenance fluid will be given as a continous infusion during the whole intraoperative period ,5 ml/kg/hour for minor surgery, 7 ml/kg/hour for moderate surgery and 10 ml/kg/hour for major surgery. This is the only intravenous maintenance fluid that will be given intraoperatively. Using near-isotonic 1% glucose solution for this age group is not yet clinical practice at our department , mostly due to fear of hypoglycemia. However, this solution is widely recommended, including European Society of Pediatric anesthesia. This study focus upon a specific age cohort with possible risk of hypoglycemia. and include a relatively large number of patients. We believe that the recommendations can be substantiated with the results from this study. Plasma glucose concentration (blood-gas analysis) will be determined at induction of anesthesia and then every 30 minutes during surgery. In the blood-gas analysis also sodium will be analysed. The concentration of ketone bodies will be measured at induction and at the end of surgery. The time of fasting will be determined and related to glucose- and ketoneconcentration. In a subgroup of subjects undergoing major surgery with expected duration > 60 minutes, endogenous glucose production and energy production will be determined using stabile isotope (6.6-D2-glucose) and indirect calorimetry respectively.


Locations(1)

Stockholm, Sweden

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ACTRN12619000833167