Outcome of Glargine Insulin in Renal Impairment Patients With Diabetic Ketoacidosis

NCT ID: NCT05219942

Last Updated: 2022-06-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2022-07-31

Brief Summary

The study aims to compare between the use of continuous low dose insulin infusion versus co-administration of low dose continuous insulin infusion and early subcutaneous insulin glargine in diabetic ketoacidosis patients with chronic renal impairment. aim to investigate the effect of using the long acting insulin analogue glargine on the resolution time of diabetic ketoacidosis in renal impairment patients who have altered insulin pharmacokinetics and pharmacodynamics and the rate of adverse effects of this approach

Detailed Description

Diabetic ketoacidosis (DKA) is one of the most common and grave acute complications of diabetes and is a significant cause of morbidity and mortality.

The current available guidelines state that the most effective means of insulin delivery during DKA is a continuous low dose infusion of regular insulin. The patients must be admitted to the ICU for frequent and close monitoring .In addition to insulin infusion, correction of dehydration, and electrolyte and acid base disorders is achieved together with identification and treatment of co-morbid precipitating factors .

"The Joint British Diabetes Societies guideline for the management of diabetic ketoacidosis" recommends continuation of a long-acting insulin analogue such as insulin glargine during the initial management of DKA because it provides background insulin when the intravenous insulin is discontinue.

Administering basal insulin concomitantly with regular insulin infusion was found to be well tolerated, associated with faster resolution of acidosis without any adverse effects; patients required a shorter duration of intravenous insulin infusion and had a lower total dose of intravenous insulin and significantly decreased hyperglycemia after discontinuation of the intravenous insulin .

Conditions

Chronic Kidney Diseases

Study Design

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

Study Groups

low dose insulin infusion +Subcutaneous saline

low dose insulin infusion +Subcutaneous saline

Group Type: PLACEBO_COMPARATOR

normal saline

Intervention Type: OTHER

regular low dose insulin infusion 0.1 IU/Kg/hour and subcutaneous saline instead of insulin glargine will be given in the control group.

low dose insulin infusion +subcutaneous Glargine insulin

low dose insulin infusion +subcutaneous Glargine insulin

Group Type: ACTIVE_COMPARATOR

Glargine

Intervention Type: DRUG

regular low dose insulin infusion 0.1 IU/Kg/hour and subcutaneous Glargine insulin (made by Sanofi®) within the first 2 hours of ICU admission. The dose of insulin glargine will be adjusted according to the calculated (eGFR \> 90 dose = 0.27 IU/kg/day, eGFR 60-89 dose = 0.25 IU/kg/day, eGFR \<60 dose = 0.19 IU/kg/day.

Interventions

Glargine

regular low dose insulin infusion 0.1 IU/Kg/hour and subcutaneous Glargine insulin (made by Sanofi®) within the first 2 hours of ICU admission. The dose of insulin glargine will be adjusted according to the calculated (eGFR \> 90 dose = 0.27 IU/kg/day, eGFR 60-89 dose = 0.25 IU/kg/day, eGFR \<60 dose = 0.19 IU/kg/day.

Intervention Type: DRUG

normal saline

regular low dose insulin infusion 0.1 IU/Kg/hour and subcutaneous saline instead of insulin glargine will be given in the control group.

Intervention Type: OTHER

Other Intervention Names

insulin

Eligibility Criteria

Inclusion Criteria

• Male and female patients.
• Type I and type II diabetes mellitus.
• Patients on insulin and/or oral hypoglycemic therapy.
• Duration of diabetes more than 5 years.
• Medical and surgical patients.

Exclusion Criteria

• Severe persistent hypotension (SBP <80 inspite of receiving 1000ml of normal saline).
• Acute myocardial infarction.
• Progressive renal failure or end stage renal disease defined as eGFR < 15ml/min.
• Liver cell failure.
• Pregnancy.
• Need for emergency surgery

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Mona Ammar

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ain Shams University

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Eeman A Bayoumi, MD

Role: CONTACT

eeman_aboubakr@med.asu.edu.eg

0021001635744

Facility Contacts

Wael A ElSwefi, MD

Role: primary

waelelswefi@yahoo.com

00201114811883

References

Barski L, Kezerle L, Zeller L, Zektser M, Jotkowitz A. New approaches to the use of insulin in patients with diabetic ketoacidosis. Eur J Intern Med. 2013 Apr;24(3):213-6. doi: 10.1016/j.ejim.2013.01.014. Epub 2013 Feb 8.

Reference Type: BACKGROUND

PMID: 23395363 (View on PubMed)

Barski L, Brandstaetter E, Sagy I, Jotkowitz A. Basal insulin for the management of diabetic ketoacidosis. Eur J Intern Med. 2018 Jan;47:14-16. doi: 10.1016/j.ejim.2017.08.025. Epub 2017 Aug 31.

Reference Type: BACKGROUND

PMID: 28864157 (View on PubMed)

Chapter 1: Definition and classification of CKD. Kidney Int Suppl (2011). 2013 Jan;3(1):19-62. doi: 10.1038/kisup.2012.64. No abstract available.

Reference Type: BACKGROUND

PMID: 25018975 (View on PubMed)

Savage MW, Dhatariya KK, Kilvert A, Rayman G, Rees JA, Courtney CH, Hilton L, Dyer PH, Hamersley MS; Joint British Diabetes Societies. Joint British Diabetes Societies guideline for the management of diabetic ketoacidosis. Diabet Med. 2011 May;28(5):508-15. doi: 10.1111/j.1464-5491.2011.03246.x.

Reference Type: BACKGROUND

PMID: 21255074 (View on PubMed)

Svensson M, Yu ZW, Eriksson JW. A small reduction in glomerular filtration is accompanied by insulin resistance in type I diabetes patients with diabetic nephrophathy. Eur J Clin Invest. 2002 Feb;32(2):100-9. doi: 10.1046/j.1365-2362.2002.00949.x.

Reference Type: BACKGROUND

PMID: 11895456 (View on PubMed)

Other Identifiers

R 103/ 2020

Identifier Type: -

Identifier Source: org_study_id