Correlation of Hospital Stay Length With the Glucose Leve... | NCT02946411

Studies
Correlation of Hospital Stay Length With the Glucose Levels After Cardiac Surgery

NCT02946411

Sponsor

Coordinación de Investigación en Salud, Mexico

Status

Unknown status

Last Update Posted

Aug 6, 2020Actual

Enrollment

48Estimated

Phase

Not provided

Conditions

Stress Hyperglycemia

Interventions

Cardiac surgery

Countries

Mexico

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2016Actual

Primary Completion Date

Dec 2021Estimated

Completion Date

Dec 2021Estimated

First Submitted Date

Oct 20, 2016

First Submission Date that Met QC Criteria

Oct 25, 2016

First Posted Date

Oct 27, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 5, 2020

Last Update Posted Date

Aug 6, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

The stress hyperglycemia commonly observed in the postoperatory period, there have been several studies to assess if there is benefit of having a strict glucose control or not.

This study will assess if there is correlation between the glucose levels measured continuously with the length of the stay in the hospital.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

48Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients		The glucose of 48 patients will be measured during 5 days after cardiac surgery.	Procedure: Cardiac surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cardiac surgery	Procedure	Glucose level will be measured after cardiac surgery.	Patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Glucose	Glucose will be continuously monitored for 5 days	5 days

Secondary Outcomes

Measure	Description	Time Frame
Hospital stay	The days that the patient remains in the hospital after the surgery.	[Days] Within the first 20 days after surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Patients with a programmed cardiac surgery

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ana Gallardo, Dr.	Investigator	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital de cardiología		Mexico City	Mexico City	06720	Mexico

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006943	Hyperglycemia

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D006348	Cardiac Surgical Procedures

Ancestor Terms

ID	Term
D013504	Cardiovascular Surgical Procedures
D013514	Surgical Procedures, Operative
D019616	Thoracic Surgical Procedures

Browse Leaves

Not provided

Browse Branches

Not provided