Hemoglobin A1c and Immediate Postsurgical Complications Diabetes Type 2

Postoperative Complications Clinical Trial

— HbA1c  

Official title:

Hemoglobin A1c and Immediate Postsurgical Complications Diabetes Type 2 (HbA1c)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01403961
• Other study ID #: 1439
• Status: Completed
• Start date: July 2011
• Est. completion date: December 2017

Study information

• Verified date: August 2019
• Source: Hospital Italiano de Buenos Aires
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1760
• Est. completion date: December 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Postoperative Complications

Locations

Country	Name	City	State
Argentina	Hospital Italiano de Buenos Aires	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Italiano de Buenos Aires

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare incidence of immediate post surgery complications in diabetic patients with HbA1c > 7 and patients with HbA1c = 7	Incidence of death, infections, cardiovascular o brainvascular disease	30 days postsurgery