Effect of EGDT on Hepatic Perfusion in Patients With Septic Shock

Septic Shock Clinical Trial

Official title:

Effect of EGDT on Hepatic Perfusion in Patients With Septic Shock

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02060773
• Other study ID #: zhongdaH
• Status: Recruiting
• Phase: N/A
• First received: February 8, 2014
• Last updated: February 8, 2014
• Start date: December 2012
• Est. completion date: February 2014

Study information

• Verified date: December 2012
• Source: Zhongda Hospital
• Contact: Xiaohua Qiu, MD
• Phone: 0086-025-83262553
• Email: xiaohua0917[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 0
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Locations

Country	Name	City	State
China	Affiliated Zhongda Hospital of Southeast University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Zhongda Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ICG-PDR and R15 before treatment, after EGDT and 24 hours after EGDT.		30 hours	Yes
Secondary	28 days mortality	Follow up to determine the mortality in 28 days after inclusion	28 days	Yes