Hemoglobin A1c and Immediate Postsurgical Complications Diabetes Type 2

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1760 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-07-31

Study Completion Date

2017-12-31

Brief Summary

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The purpose of this study is to evaluate Hemoglobin A1c values previous to a surgery in patients with diabetes type II and the complication incidence in immediate post surgery.

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Detailed Description

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The diabetes is a highly prevalent disease in patients who undergo an evaluation previous to a surgery. The most efficient glucose control, in patients with diabetes type II, reduces the risk of microvascular complications. Diabectic patients who underwent scheduled cardivacular or noncardiovascular surgeries show an increase rate of immediate and long-term complications. The most frequent complications are infections, cardiovascular events and death.

Intensive insulinisation during cardiovascular surgery reduces the risk of a new coronary event in the immediate post surgery. No studies have been found that show the evaluation of Hemoglobin A1c values before the surgery and the immediate post surgery complications.

A poor glycemic control has been associated to a large number of chronic complications like diabetic neuropathy, nephropathy, retinopathy and infection disease. The Hemoglobin A1c is used like a marker of the glycemic control in the last 120 days and has a correlation with the no enzyme glicosilation. This marker could have a relation with the complication after the programmed surgery.

This study will evaluate the incidence of complications in the immediate post operatory in patients with diabetes type II in relation to the hemoglobin A1c before the surgery. If the hemoglobin A1c has a correlation with the incidence of cardiovascular complications, this could mark a change in the therapeutic measures prior the programmed surgery.

Conditions

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Postoperative Complications

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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HbA1c > 7

Diabetic patients with HbA1c \> 7

No interventions assigned to this group

HbA1c ≤ 7

Diabetic patients with HbA1c ≤ 7

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Patients older than 18 years with diagnosed of diabetes type 2
2. Programmed major surgery with expected hospitalization longer than 24 hours

Exclusion Criteria

1. Refusal to participate in the study or the informed consent process.
2. Programmed cardiac or coronary surgery
3. Technical complications inherent to surgical or anatomical abnormalities.
4. Pregnant women.
5. Active infection prior to performing surgery

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No