NCT02060773

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2012

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

Study Start

First participant enrolled

December 1, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

February 8, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 12, 2014

Completed
Last Updated

February 12, 2014

Status Verified

December 1, 2012

Enrollment Period

1.2 years

First QC Date

February 8, 2014

Last Update Submit

February 8, 2014

Conditions

Septic Shock

Keywords

Septic shockEarly goal directed therapyFluid resuscitationHepatic perfusionIndocyanine Green

Outcome Measures

Primary Outcomes (1)

  • ICG-PDR and R15 before treatment, after EGDT and 24 hours after EGDT.

    30 hours

Secondary Outcomes (1)

  • 28 days mortality

    28 days

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Affiliated Zhongda Hospital of Southeast University

Nanjing, Jiangsu, 210009, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 27411453DERIVED

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Central Study Contacts

Xiaohua Qiu, MD

CONTACT

0086-025-83262553xiaohua0917@163.com

Study Design

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

Study Record Dates

First Submitted

February 8, 2014

First Posted

February 12, 2014

Study Start

December 1, 2012

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

February 12, 2014

Record last verified: 2012-12

Locations

CN(1)