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

NCT02305199 | Withdrawn DMC

• 1 other identifier: YeungnamU
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes Mellitus, Type 2; Hartmann's solution

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Postoperative Stress hormone level

  up to postoperative day 2

Study Arms (2)

Hartmanns' solution

ACTIVE COMPARATOR

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

Normal saline

ACTIVE COMPARATOR

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

Interventions

Hartmann's solution 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.

Also known as: Hartmann solution 1000 ml, Choonwae pharmacy

Hartmanns' solution

Normal saline DRUG

Fluid containing Sodium chloride 9 g/L

Also known as: Normal Saline 1 L, Choonwae

Normal saline

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type II diabetes patients who are included in American Society of Anesthesiologists Physical Status Classification I-III.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yeungnam University College of Medicine: lead

Study Sites (1)

Yeungnam University Hospital

Daegu, 705-717, South Korea

Location

Related Publications (2)

• 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.

  PMID: 763155 BACKGROUND

• 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.

  PMID: 3065017 RESULT

Related Links

• Glucose metabolism in man: responses to intravenous glucose infusion
• Managing diabetic surgical patients with glucose-free saline and insulin

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Ringer's Lactate; Saline Solution

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Sung Mee Jung, MD

  Yeungnam University College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 21, 2014
• First Posted: December 2, 2014
• Study Start: January 1, 2015
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: April 20, 2017

Record last verified: 2017-04

Locations

KR (1)