Hyperglycemia in Renal Transplantation

NCT01643382 | Completed Results DMC

• 1 other identifier: HiRT 042918
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Based on multiple prior studies, kidney transplant recipients with diabetes are at higher risk for poor initial graft function after transplant. Our study is designed to determine if tight blood sugar control around the time of kidney transplant will improve short term graft function.

Conditions

Diabetes; End Stage Renal Disease

Keywords

diabetes; kidney transplant; end stage renal disease; delayed draft function

Outcome Measures

Primary Outcomes (1)

• Incidence of Poor Graft Function After Kidney Transplant

  Our primary endpoint will be poor initial graft function defined by the occurrence of DGF (defined by a decrease in serum creatinine of \<10%/day for 3 consecutive days after transplant) or slow graft function (serum creatinine \>3 mg/dL 5 days after transplant without dialysis)

  7 days after transplant

Study Arms (2)

Tight glucose control

EXPERIMENTAL

Patients randomized to the tight glucose control arm will be placed on an insulin infusion, or continuous low dose insulin drip.

Drug: Insulin

Standard glucose control

ACTIVE COMPARATOR

Patients randomized to the standard glucose control group will be given subcutaneous doses of insulin every few hours based on their blood sugar.

Drug: Insulin, Asp(B28)-

Interventions

Insulin DRUG

Insulin will be given in a continuous low dose infusion. The infusion will be adjusted based on the patient's blood sugar with the goal of keeping the level between 100-140 mg/dL

Tight glucose control

Insulin, Asp(B28)- DRUG

Insulin will be given through subcutaneous injection every few hours based on the patient's blood sugar level.

Standard glucose control

Eligibility Criteria

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

You may qualify if:

• adult patients
• diabetic
• end stage renal disease undergoing cadaveric renal transplant

You may not qualify if:

• enrolled in concurrent study to test impact of a drug on graft function after transplant

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California San Francisco

San Francisco, California, 94123, United States

Location

Related Publications (5)

• Parekh J, Niemann CU, Dang K, Hirose R. Intraoperative hyperglycemia augments ischemia reperfusion injury in renal transplantation: a prospective study. J Transplant. 2011;2011:652458. doi: 10.1155/2011/652458. Epub 2011 Sep 4.

  PMID: 21904663 BACKGROUND

• Parekh J, Bostrom A, Feng S. Diabetes mellitus: a risk factor for delayed graft function after deceased donor kidney transplantation. Am J Transplant. 2010 Feb;10(2):298-303. doi: 10.1111/j.1600-6143.2009.02936.x. Epub 2010 Jan 6.

  PMID: 20055796 BACKGROUND

• Parekh J, Roll GR, Wisel S, Rushakoff RJ, Hirose R. Effect of moderately intense perioperative glucose control on renal allograft function: a pilot randomized controlled trial in renal transplantation. Clin Transplant. 2016 Oct;30(10):1242-1249. doi: 10.1111/ctr.12811. Epub 2016 Sep 24.

  PMID: 27423055 RESULT

• Bellon F, Sola I, Gimenez-Perez G, Hernandez M, Metzendorf MI, Rubinat E, Mauricio D. Perioperative glycaemic control for people with diabetes undergoing surgery. Cochrane Database Syst Rev. 2023 Aug 1;8(8):CD007315. doi: 10.1002/14651858.CD007315.pub3.

  PMID: 37526194 DERIVED

• Lo C, Toyama T, Oshima M, Jun M, Chin KL, Hawley CM, Zoungas S. Glucose-lowering agents for treating pre-existing and new-onset diabetes in kidney transplant recipients. Cochrane Database Syst Rev. 2020 Jul 30;8(8):CD009966. doi: 10.1002/14651858.CD009966.pub3.

  PMID: 32803882 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Kidney Failure, Chronic

Interventions

Insulin; Insulin Aspart

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Short-Acting

Results Point of Contact

• Title: Justin Parekh, MD, MAS
• Organization: University of California, San Francisco

justin.parekh@ucsfmedctr.org

415-595-3707

Study Officials

• Justin Parekh, MD, MAS

  UCSF Department of Surgery

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2012
• First Posted: July 18, 2012
• Study Start: August 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: November 5, 2020
• Results First Posted: November 5, 2020

Record last verified: 2020-10

Locations

US (1)