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

NCT ID: NCT02305199

Last Updated: 2017-04-20

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-01
• Study Completion Date: 2017-04-01

Brief Summary

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

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Hartmanns' solution

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.

Group Type: ACTIVE_COMPARATOR

Hartmann's solution

Intervention Type: DRUG

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.

Normal saline

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

Group Type: ACTIVE_COMPARATOR

Normal saline

Intervention Type: DRUG

Fluid containing Sodium chloride 9 g/L

Interventions

Hartmann's solution

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.

Intervention Type: DRUG

Normal saline

Fluid containing Sodium chloride 9 g/L

Intervention Type: DRUG

Other Intervention Names

Hartmann solution 1000 ml, Choonwae pharmacy; Normal Saline 1 L, Choonwae

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yeungnam University College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Sung Mee Jung

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sung Mee Jung, MD

Role: PRINCIPAL_INVESTIGATOR

Yeungnam University College of Medicine

Locations

Yeungnam University Hospital

Daegu, , South Korea

Countries

South Korea

References

Wolfe RR, Allsop JR, Burke JF. Glucose metabolism in man: responses to intravenous glucose infusion. Metabolism. 1979 Mar;28(3):210-20. doi: 10.1016/0026-0495(79)90066-0.

Reference Type: BACKGROUND

PMID: 763155 (View on PubMed)

Sato T, Hoshi H, Kumon T, Kitakaze Y, Watanabe R, Kobayashi T, Yoshinaga K. Managing diabetic surgical patients with glucose-free saline and insulin. Diabetes Res Clin Pract. 1988 Sep 5;5(3):191-5. doi: 10.1016/s0168-8227(88)80087-1.

Reference Type: RESULT

PMID: 3065017 (View on PubMed)

Related Links

http://www.ncbi.nlm.nih.gov/pubmed/763155

Glucose metabolism in man: responses to intravenous glucose infusion

http://www.ncbi.nlm.nih.gov/pubmed/3065017

Managing diabetic surgical patients with glucose-free saline and insulin

Other Identifiers

YeungnamU

Identifier Type: -

Identifier Source: org_study_id