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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Hospital Italiano de Buenos Aires.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Hospital Italiano de Buenos Aires
ClinicalTrials.gov Identifier:
NCT01403961
First received: July 26, 2011
Last updated: NA
Last verified: June 2011
History: No changes posted
  Purpose

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


Condition
Postoperative Complications

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Hemoglobin A1c and Immediate Postsurgical Complications Diabetes Type 2 (HbA1c)

Resource links provided by NLM:


Further study details as provided by Hospital Italiano de Buenos Aires:

Primary Outcome Measures:
  • Compare incidence of immediate post surgery complications in diabetic patients with HbA1c > 7 and patients with HbA1c ≤ 7 [ Time Frame: 30 days postsurgery ] [ Designated as safety issue: No ]
    Incidence of death, infections, cardiovascular o brainvascular disease


Estimated Enrollment: 1760
Study Start Date: July 2011
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
HbA1c ≤ 7
HbA1c > 7

Detailed Description:

The diabetes is a increased prevalence disease in the patients that need a evaluation previous to a surgery. The best glucose control, in patients with diabetes type II, decrease the risk of microvascular complications. The patients with diabetes how pass by a cardivacular or no-cardiovascular surgery have more immediate and late complications. The most frequently complications are infection, cardiovascular events and dead.

The intensive insulinization during the cardiovascular surgery decrease the risk of a new coronary event in the immediate post surgery. There no studies that evaluated the values of Hemoglobin A1c before the surgery and the immediate post surgery complications.

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

This study will devalued 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 made a change in the therapeutic before the programmed surgery.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

adult diabetic patients

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01403961

Contacts
Contact: Javier Giunta, MD +541149590200 ext 4419 javier.giunta@hospitalitaliano.org.ar

Locations
Argentina
Hospital Italiano de Buenos Aires Not yet recruiting
Buenos Aires, Argentina, C1181ACH
Contact: Javier Giunta, MD    541149590200 ext 4419    javier.giunta@hospitalitaliano.org.ar   
Principal Investigator: Diego Giunta, MD         
Sponsors and Collaborators
Hospital Italiano de Buenos Aires
Investigators
Principal Investigator: Diego Giunta, MD AIMI. HIBA.
Study Director: Javier GIunta, MD HIBA
Study Chair: Carlos Bonofiglio, MD HIBA
Study Chair: Leon Litwak, MD HIBA
  More Information

No publications provided

Responsible Party: Diego Giunta, Hospital Italiano de Buenos Aires
ClinicalTrials.gov Identifier: NCT01403961     History of Changes
Other Study ID Numbers: 1439
Study First Received: July 26, 2011
Last Updated: July 26, 2011
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Postoperative Complications
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 22, 2014