Effect of EGDT on Hepatic Perfusion in Patients With Sept... | NCT02060773

Studies
Effect of EGDT on Hepatic Perfusion in Patients With Septic Shock

NCT02060773

Sponsor

Zhongda Hospital

Status

Unknown status

Last Update Posted

Feb 12, 2014Estimated

Enrollment

Not provided

Phase

Not provided

Conditions

Septic Shock

Interventions

Not provided

Countries

China

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

Dec 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2012

Primary Completion Date

Feb 2014Estimated

Completion Date

Feb 2014Estimated

First Submitted Date

Feb 8, 2014

First Submission Date that Met QC Criteria

Feb 8, 2014

First Posted Date

Feb 12, 2014Estimated

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

Feb 8, 2014

Last Update Posted Date

Feb 12, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

To observe the effect of early goal directed therapy (EGDT) on hepatic perfusion in patients with septic shock.

Hypothesis: Hepatic perfusion did not improved after EGDT in patients with septic shock.

Detailed Description

Objective To observe the effect of early goal directed therapy (EGDT) on hepatic perfusion in patients with septic shock.

Methods A prospective observational study was carried out. The eligible patients were treated with the standard procedure of EGDT. The hemodynamic data were recorded. Oxygen metabolism and hepatic function were monitored. Indocyanine clearance test was applied to detect the hepatic perfusion. Hemodynamics, hepatic perfusion, oxygen metabolism and hepatic function were compared before treatment, after EGDT and 24 hours after EGDT.

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

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
ICG-PDR and R15 before treatment, after EGDT and 24 hours after EGDT.		30 hours

Secondary Outcomes

Measure	Description	Time Frame
28 days mortality	Follow up to determine the mortality in 28 days after inclusion	28 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with septic shock
at least one of the EGDT criteria not achieved
informed consent accepted

Exclusion Criteria:

ages below 18 or above 90
pregnancy
the time elapsed over 24 hours after onset of septic shock
chronic liver disease
terminal stage of disease
brain death
other types of shock
brain injury
allergic to iodine or indocyanine

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Critical patients with early septic shock admitted to ICU within 24 hours after onset

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xiaohua Qiu, MD	Contact	0086-025-83262553		xiaohua0917@163.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Affiliated Zhongda Hospital of Southeast University	Recruiting	Nanjing	Jiangsu	210009	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27411453	Derived	Zhang XW, Xie JF, Liu AR, Huang YZ, Guo FM, Yang CS, Yang Y, Qiu HB. Hepatic Perfusion Alterations in Septic Shock Patients: Impact of Early Goal-directed Therapy. Chin Med J (Engl). 2016 Jul 20;129(14):1666-73. doi: 10.4103/0366-6999.185865.

ID	Term
D018805	Sepsis
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation