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Effect of EGDT on Hepatic Perfusion in Patients With Septic Shock

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2012 by Xiaohua Qiu, Zhongda Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02060773
First Posted: February 12, 2014
Last Update Posted: February 12, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Xiaohua Qiu, Zhongda Hospital
  Purpose

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.


Condition
Septic Shock

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of EGDT on Hepatic Perfusion in Patients With Septic Shock

Resource links provided by NLM:


Further study details as provided by Xiaohua Qiu, Zhongda Hospital:

Primary Outcome Measures:
  • ICG-PDR and R15 before treatment, after EGDT and 24 hours after EGDT. [ Time Frame: 30 hours ]

Secondary Outcome Measures:
  • 28 days mortality [ Time Frame: 28 days ]
    Follow up to determine the mortality in 28 days after inclusion


Study Start Date: December 2012
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
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.

  Eligibility

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Critical patients with early septic shock admitted to ICU within 24 hours after onset
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. ages below 18 or above 90
  2. pregnancy
  3. the time elapsed over 24 hours after onset of septic shock
  4. chronic liver disease
  5. terminal stage of disease
  6. brain death
  7. other types of shock
  8. brain injury
  9. allergic to iodine or indocyanine
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02060773


Contacts
Contact: Xiaohua Qiu, MD 0086-025-83262553 xiaohua0917@163.com

Locations
China, Jiangsu
Affiliated Zhongda Hospital of Southeast University Recruiting
Nanjing, Jiangsu, China, 210009
Contact: Xiaohua Qiu, MD    0086-025-83262553    xiaohua0917@163.com   
Principal Investigator: Xiwen Zhang, MD         
Sub-Investigator: Xiaohua Qiu, MD         
Sponsors and Collaborators
Zhongda Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Xiaohua Qiu, physician, Zhongda Hospital
ClinicalTrials.gov Identifier: NCT02060773     History of Changes
Other Study ID Numbers: zhongdaH
First Submitted: February 8, 2014
First Posted: February 12, 2014
Last Update Posted: February 12, 2014
Last Verified: December 2012

Keywords provided by Xiaohua Qiu, Zhongda Hospital:
Septic shock
Early goal directed therapy
Fluid resuscitation
Hepatic perfusion
Indocyanine Green

Additional relevant MeSH terms:
Shock
Shock, Septic
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation