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HyperglycemiaNCT00404950

Effects of Hyperglycemia During Cardiopulmonary Bypass on Renal Function

An observational study of Hyperglycemia and Diabetes, run by Weill Medical College of Cornell University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To determine whether intraoperative hyperglycemia potentiates renal injury in the setting of cardiac surgery requiring cardiopulmonary bypass. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Hyperglycemia, Diabetes
How many people
200 participants
Where
1 siteUnited States
Study dates
Jul 2005to Jul 2012
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients undergoing on pump cardiopulmonary bypass for either myocardial revascularization (coronary artery bypass graft) or valvular surgery (valve repair or replacement)

Who may be able to join

  • Male and female patients ≥ 50 years of age
  • Patients undergoing on pump cardiopulmonary bypass for either myocardial revascularization (coronary artery bypass graft) or valvular surgery (valve repair or replacement)

Who cannot join

  • Patients with insulin dependent diabetes
  • Patients with preexisting renal dysfunction defined as Creatinine> 2 mg/dl
  • Patients in need of emergency cardiac procedures

Trial locations and contacts

1 site in 1 country.

United States1 site
  • The New York Presbyterian Hospital - Weill Medical College of Cornell University

    New York, New York, 10021

Other trials in United States

About this study

To determine whether intraoperative hyperglycemia potentiates renal injury in the setting of cardiac surgery requiring cardiopulmonary bypass.

Read the detailed description

Significance:

Postoperative renal dysfunction is a common complication of cardiopulmonary bypass occurring in nearly 8% of all patients undergoing myocardial revascularization. Both diabetes and preoperative hyperglycemia are independent risk factors for postoperative renal dysfunction after coronary artery bypass surgery.

The cause of renal injury is multifactoral and in most cases involves renal ischemia from alteration of renal perfusion, resistance, metabolic byproducts (free-radical species), inflammatory mediators and embolic processes.

In the setting of ischemia, specifically, neuronal, hyperglycemia has been shown to worsen neurologic outcome and interfere with wound healing-possibly increasing the incidence of wound infection.

Hyperglycemia is common during cardiopulmonary bypass in both diabetic and non-diabetic patients as a result of altered glucose regulation during hypothermic conditions (body temperature actively cooled to 28 degree centigrade) and, more importantly, from delivery of cardioplegia to arrest the heart allowing for surgical repair in a non-beating heart. The cardioplegia is rich in potassium, among other agents, believed to offer cardioprotection during cardiopulmonary bypass and is prepared in Dextrose 5% and normal saline. On average, each patient receives nearly 2 liters of this solution, amounting to 100 grams or more of glucose. In this setting, hyperglycemia is also promoted from insulin suppression, stress hormone induced gluconeogenesis and enhanced tubular resorption.

Only recently have perioperative clinicians become aware about potential ischemic effects of hyperglycemia during bypass and the need to maintain 'tight' control of glucose to avoid stroke. This practice, however, is inconsistent and mostly applied to diabetic patients.

We hypothesize that tubular injury may be exacerbated by hyperglycemia in non-diabetic patients while undergoing hypothermic cardiopulmonary bypass and have undertaken this prospective observational study to investigate the relationship between intraoperative glucose and postoperative renal dysfunction.

Methodology:

We plan to study to 200 patients ≥ 50 years of age scheduled for procedures requiring cardiopulmonary bypass whether for coronary revascularization or valvular surgery. After informed consent is obtained each patient's preoperative lab values consisting of serum glucose, urine glucose, creatinine and BUN will be noted. Each patient's pre-induction hemodynamics will also be noted. During bypass, serum and urine glucose will be measured every 20 minutes in addition to collecting information on temperature of cardioplegic solution, lowest patient temperature, time of bypass, and use of diuretics, or vasoactive drugs. Additional sampling of serum creatinine and glucose and vital signs will take place upon arrival in the cardiac intensive care unit after surgery and throughout hospitalization as is standard of care in cardiac surgery at this institution. No extra samples will be taken but the standard measurements will be observed. The clinical outcome of interest is a new onset of renal dysfunction defined as a post-operative serum creatinine change of 0.5 mg/dl or greater after surgery.

Inclusion Criteria:

  1. Male and female patients ≥ 50 years of age
  2. Patients undergoing on pump cardiopulmonary bypass for either myocardial revascularization (coronary artery bypass graft) or valvular surgery (valve repair or replacement)

Exclusion Criteria:

  1. Patients with insulin dependent diabetes
  2. Patients with preexisting renal dysfunction defined as Creatinine> 2 mg/dl
  3. Patients in need of emergency cardiac procedures
Keywords
hyperglycemia, cardiopulmonary bypass, renal injury, diabetes
Medical subject headings
Hyperglycemia, Diabetes Mellitus

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2006 (estimated)
  2. Study startJul 2005
  3. Primary completionOct 2010
  4. Study completionJul 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00404950
Sponsor's protocol ID
0408007400
Status last verified
Feb 2017
First submitted
28 Nov 2006
Last updated
6 Feb 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No: Will not share

Questions about this trial

What is this clinical trial studying?

An observational study of Hyperglycemia and Diabetes, run by Weill Medical College of Cornell University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2017.

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