Clinical trial NCT01403961: Hemoglobin A1c and Immediate Postsurgical Complications Diabetes Type 2
Official title: Hemoglobin A1c and Immediate Postsurgical Complications Diabetes Type 2 (HbA1c)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Complications
Lead sponsor: Hospital Italiano de Buenos Aires
Sponsor class: OTHER
First posted: 2011-07-27
Enrollment: 1760
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: adult diabetic patients

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Compare incidence of immediate post surgery complications in diabetic patients with HbA1c > 7 and patients with HbA1c ≤ 7
timeFrame: 30 days postsurgery
Secondary outcomes:
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
Study officials:
affiliation: AIMI. HIBA.
name: Diego Giunta, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: HIBA
name: Javier GIunta, MD
role: STUDY_DIRECTOR
affiliation: HIBA
name: Carlos Bonofiglio, MD
role: STUDY_CHAIR
affiliation: HIBA
name: Leon Litwak, MD
role: STUDY_CHAIR
References: