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

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02305199
Enrollment
0
Registered
2014-12-02
Start date
2015-01-01
Completion date
2017-04-01
Last updated
2017-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes Mellitus, Type 2, Hartmann's solution

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.

Interventions

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.

DRUGNormal saline

Fluid containing Sodium chloride 9 g/L

Sponsors

Yeungnam University College of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Postoperative glucose levelup to postoperative day 2Being 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

Secondary

MeasureTime frameDescription
Postoperative Stress hormone levelup to postoperative day 2Insulin, Glucagon, Free Fatty Acid, Cortisol, Lactate, Ketone body are checked at one hour after the surgery, and first and second postoperative days

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026