NCT02946411

Brief Summary

The study is designed to test if there is any correlation between the glucose levels in the postoperatory period and the length of hospital stay.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

October 20, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 27, 2016

Completed
5 days until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

August 6, 2020

Status Verified

August 1, 2020

Enrollment Period

5.1 years

First QC Date

October 20, 2016

Last Update Submit

August 5, 2020

Conditions

Stress Hyperglycemia

Keywords

Hyperglycemia

Outcome Measures

Primary Outcomes (1)

  • Glucose

    Glucose will be continuously monitored for 5 days

    5 days

Secondary Outcomes (1)

  • Hospital stay

    [Days] Within the first 20 days after surgery

Study Arms (1)

Patients

The glucose of 48 patients will be measured during 5 days after cardiac surgery.

Procedure: Cardiac surgery

Interventions

Cardiac surgeryPROCEDURE

Glucose level will be measured after cardiac surgery.

Patients

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Patients with a programmed cardiac surgery

You may qualify if:

  • Physical status classification of the American Society of Anesthesiologists (ASA) II-IV
  • Patients programmed for cardiac surgery
  • Any body mass index

You may not qualify if:

  • Pregnant women
  • Chronic Kidney Disease (CKD) Stage 2 or higher

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de cardiología

Mexico City, Mexico City, 06720, Mexico

Location

MeSH Terms

Conditions

Hyperglycemia

Interventions

Cardiac Surgical Procedures

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cardiovascular Surgical ProceduresSurgical Procedures, OperativeThoracic Surgical Procedures

Study Officials

  • Ana Gallardo, Dr.

    Investigator

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2016

First Posted

October 27, 2016

Study Start

November 1, 2016

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

August 6, 2020

Record last verified: 2020-08

Locations

ME(1)