Hemoglobin A1c and Immediate Postsurgical Complications Diabetes Type 2

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01403961

Acronym

HbA1c

Enrollment

1760

Registered

2011-07-27

Start date

2011-07-31

Completion date

2017-12-31

Last updated

2019-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Complications

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

Argentina

Outcome results