Hartmann's Solution and Normal Saline in Type II Diabetes Patients

Study Overview
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Brief Summary
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The purpose of this study is to determine whether perioperative use of Hartmann's solution in type II diabetes patients increases blood glucose level after surgery. The investigators expect the result to broaden the choice of fluid for diabetic patients and hopefully to diminish the side effects manifested by the excess use of normal saline.

Detailed Description
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Hyperglycemia is an independent risk factor for poor outcomes in diabetic patients experiencing sudden cardiac death, myocardial infarction, cerebrovascular accident. During surgery, activation of the neuroendocrine system by surgical stress releases stress-induced hormones such as cortisol, glucagon, epinephrine, and growth hormones and it leads to hepatic glucogenesis and glycogenolysis. Acute perioperative hyperglycemia induces decreased microvascular reactivity to dilatory agents like bradykinin, increased inflammatory cytokines, and impaired neutrophil activity. This impaired neuroendocrine and immune system leads to increased inflammation and multiple organ system dysfunction. Thomas and Alberti showed postoperative use of 1 litre of Hartmann's solution was associated with a 7.5 mmol/L increase in plasma glucose concentrations, compared with an increase of 2.1 mmol/L in diabetic patients who received no intravenous fluids. Since then, normal saline has been preferred over Hartmann's solution in fear of acute hyperglycemia during postoperative period. However, a recent review suggested that the maximum increase in glucose concentration with 1 L of Hartmann's solution would be about 1 mmol/L (about 18 mg/dL) ,with a much lower effect on blood glucose in clinical practice. In fact, according to 2012 National Health Services (NHS) diabetes guideline for the perioperative management of the adult patient with diabetes, Hartmann's solution is used in preference to 0.9% saline. Excess use of normal saline could yield complications such as hyperglycemia and metabolic acidosis. To date, a few studies have examined the effects of preoperative blood glucose levels on outcomes in patients undergoing surgery, and no prospective randomized investigations have been reported. The investigators are going to find out if Hartmann's solution actually raises postoperative glucose and insulin level by comparing two groups of diabetic patients using either Hartmann's solution or normal saline. The investigators expect the result to broaden the choice of fluid for diabetic patients undergoing surgery and hopefully to diminish the side effects manifested by the excess use of normal saline.

Official Title
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Comparison of Hartmann's Solution and Normal Saline on Postoperative Blood Glucose and Insulin Levels in Type II Diabetic Patients

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Hartmann's solution
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type II diabetes patients who are included in American Society of Anesthesiologists Physical Status Classification I-III. Exclusion Criteria: emergency surgery, acute or chronic kidney disease, electrolyte imbalance such as hypernatremia, hyponatremia, hyperkalemia or hypokalemia, liver dysfunction, unexpected hemodynamic instability due to excess bleeding, postoperative ventilatory care and trauma patients.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hartmanns' solution<br>All the participants went on a fast at midnight and 1 L of 5% dextrose fluid containing 10 units of regular insulin (RI) and 40 mEq of potassium was administered intravenously. On participant's arrival to the operation room, fluid from the ward was immediately removed and replaced it with 1 L of unknown fluid completely sealed in black bag. Neither the participant nor the researcher were aware of the type of the fluid. After the fluid change, general anesthesia was induced. Intraoperative blood glucose was checked every one hours and 20% dextrose was injected if the number was below 100 and RI was injected if the number was checked over 200. | Drug: Hartmann's solution<br>* Hartmann's solution containing 200 mg/L of calcium chloride, 300 mg/L of potassium chloride, 6 g/L of Sodium chloride, 3.1 g/L of Sodium lactate.<br>* Other names: Hartmann solution 1000 ml, Choonwae pharmacy;|
| Active Comparator: Normal saline<br>All the participants went on a fast at midnight and 1 L of 5% dextrose fluid containing 10 units of RI and 40 mEq of potassium was administered intravenously. On participant's arrival to the operation room, fluid from the ward was immediately removed and replaced it with 1 L of unknown fluid completely sealed in black bag. Neither the participant nor the researcher were aware of the type of the fluid. After the fluid change, general anesthesia was induced. Intraoperative blood glucose was checked every one hours and 20% dextrose was injected if the number was below 100 and RI was injected if the number was checked over 200 | Drug: Normal saline<br>* Fluid containing Sodium chloride 9 g/L<br>* Other names: Normal Saline 1 L, Choonwae;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative glucose level | Being the first blood sampling done a day before the surgery as the baseline, postoperative blood glucose levels checked at one hour after the surgery, and first and second postoperative days | up to postoperative day 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Stress hormone level | Insulin, Glucagon, Free Fatty Acid, Cortisol, Lactate, Ketone body are checked at one hour after the surgery, and first and second postoperative days | up to postoperative day 2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus, Type 2, Hartmann's solution