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

Plain Language Summary

Simplified for easier understanding

When babies aged 1 to 12 months undergo surgery under general anaesthesia, they need intravenous fluids to maintain hydration, blood pressure, and stable blood sugar. The type of fluid used — particularly how much glucose it contains — is important, because too little glucose can cause dangerously low blood sugar (hypoglycaemia), while too much can cause high blood sugar. European guidelines recommend a near-normal salt solution with a small amount of glucose, but the ideal concentration has not been well established in clinical practice. This study investigates whether giving a 1% glucose solution during surgery is safe for infants aged 1–12 months and keeps blood sugar in a healthy range. Researchers at Karolinska University Hospital in Stockholm will closely monitor glucose levels and study how babies' bodies process sugar during surgery. Healthy infants aged 1–12 months who are undergoing planned surgery are eligible. Babies with metabolic or endocrine diseases, liver disease, malnutrition, or very small birth size are excluded, as are those who have already received glucose infusions before surgery. Answering this question will give anaesthesiologists clearer, evidence-based guidance on the safest fluid to use for babies in the operating room.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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