NCT01403961

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,760

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

July 26, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 27, 2011

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

August 13, 2019

Status Verified

August 1, 2019

Enrollment Period

5.4 years

First QC Date

July 26, 2011

Last Update Submit

August 9, 2019

Conditions

Postoperative Complications

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

HbA1c > 7

Diabetic patients with HbA1c \> 7

HbA1c ≤ 7

Diabetic patients with HbA1c ≤ 7

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

adult diabetic patients

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Italiano de Buenos Aires

Buenos Aires, C1181ACH, Argentina

Location

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Diego Giunta, MD

    AIMI. HIBA.

    PRINCIPAL INVESTIGATOR

  • Javier GIunta, MD

    HIBA

    STUDY DIRECTOR

  • Carlos Bonofiglio, MD

    HIBA

    STUDY CHAIR

  • Leon Litwak, MD

    HIBA

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 26, 2011

First Posted

July 27, 2011

Study Start

July 1, 2011

Primary Completion

December 1, 2016

Study Completion

December 1, 2017

Last Updated

August 13, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

AR(1)