Hyperglycemia in Surgical Infections

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2011-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The primary purpose of this study is to evaluate two glycemic control regimens on clinical outcome in patients with necrotizing soft tissue infections. Secondary aim is to evaluate the inflammatory and immune responses to the glycemic control regimens.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Effect of Tight Glycemic Control on Surgical Site Infection Rates in Patients Undergoing Open Heart Surgery

NCT01831154

Diabetes Hyperglycemia Surgical Site Infection

COMPLETED NA

Outcomes Study of Hyperinsulinemic Glucose Control in Cardiac Surgery

NCT00524472

Cardiac Surgery

COMPLETED NA

The Association Between Peri-Operative Hyperglycemia and Major Morbidity and Mortality

NCT00487162

Hyperglycemia

TERMINATED NA

Impact of Severe Intraoperative Hyperglycemia on Infection Rate After Elective Intracranial Interventions

NCT04285359

Hyperglycemia Craniotomy Infection Post Op

COMPLETED

Effect of High Dose Insulin on Infectious Complications Following Major Surgery

NCT01528189

Surgical Site Infection After Major Surgery

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a multi-center explanatory trial of strict glycemic control for surgical patients with necrotizing soft tissue infection (NSTI). The primary objective of this study is to verify feasibility of the intervention, provide unbiased and evidence-based estimates of treatment effects, and obtain data needed to design and direct a larger multi-center trial if necessary. The multi-center trial (n \>100) will have adequate power to identify a 30% difference in favorable outcome defined as discharge alive from the hospital without an amputation in less than the median number of hospital days. Secondary objectives include evaluation of specific hypotheses relating the intervention to cytokine and neutrophil responses. These preliminary data will provide the basis for future research and grant applications, lend insight into the mechanisms by which hyperglycemia results in adverse effects, and improve outcome through the development of evidence-based therapeutic strategies for patient care.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Necrotizing Fasciitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Strict glycemic control with a blood glucose target range of 80-110 mg/dL

Group Type OTHER

Strict Glycemic control

Intervention Type DRUG

Blood glucose target range is 80-110 mg/dL.

2

Conventional glycemic control with blood glucose target range of 110-140 mg/dL

Group Type OTHER

Conventional Glycemic Control

Intervention Type DRUG

Blood glucose target range is 110-140 mg/dL.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Strict Glycemic control

Blood glucose target range is 80-110 mg/dL.

Intervention Type DRUG

Conventional Glycemic Control

Blood glucose target range is 110-140 mg/dL.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients will be enrolled at one of the following centers: the LBJ General Hospital (UT-Houston), the Ben Taub General Hospital (Baylor Houston), The Methodist Hospital (Texas Medical Center), or the University of Texas Health Science Center at San Antonio and the Brooke Army Medical Center.
* We will attempt to enroll all eligible patients with a diagnosis of a necrotizing soft tissue infection (NSTI), including Fournier's gangrene, confirmed in the operating room regardless of age, ethnicity or gender.