Septic ShockNCT02060773
Effect of EGDT on Hepatic Perfusion in Patients With Septic Shock
An observational study of Septic Shock, run by Zhongda Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Septic Shock
- How many people
- Not given
- Where
- 1 siteChina
- Study dates
- Dec 2012to Feb 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Critical patients with early septic shock admitted to ICU within 24 hours after onset
Who may be able to join
- patients with septic shock
- at least one of the EGDT criteria not achieved
- informed consent accepted
Who cannot join
- 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
Show all 9Show fewer
- other types of shock
- brain injury
- allergic to iodine or indocyanine
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Affiliated Zhongda Hospital of Southeast University
Nanjing, Jiangsu, 210009
Xiaohua Qiu, MD, 0086-025-83262553, xiaohua0917@163.com
Xiwen Zhang, MD
About this study
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.
Read the 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.
- Conditions
- Septic Shock
- Keywords
- Septic shock, Early goal directed therapy, Fluid resuscitation, Hepatic perfusion, Indocyanine Green
- Medical subject headings
- Shock, Septic
What is being measured
The primary outcome is the main question the study is designed to answer.
ICG-PDR and R15 before treatment, after EGDT and 24 hours after EGDT.
Measured: 30 hours
Secondary outcomes (1)
28 days mortality
Follow up to determine the mortality in 28 days after inclusion
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2014 (estimated)
- Study startDec 2012
- Primary completionFeb 2014 (estimated)
- Study completionFeb 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- Zhongda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaohua Qiu, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02060773
- Sponsor's protocol ID
- zhongdaH
- Status last verified
- Dec 2012
- First submitted
- 8 Feb 2014
- Last updated
- 12 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27411453
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of EGDT on Hepatic Perfusion in Patients With Septic Shock
- ClinicalTrials.gov ID
- NCT02060773
- Acronym / sponsor ID
- zhongdaH
- Conditions
- Septic Shock
- Keywords
- Septic shock, Early goal directed therapy, Fluid resuscitation, Hepatic perfusion, Indocyanine Green
- Study type
- Observational
- Recruitment status
- Unknown status
- Lead sponsor
- Zhongda HospitalUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Feb 2014 (estimated)
- Study completion
- Feb 2014 (estimated)
- First posted
- 12 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critical patients with early septic shock admitted to ICU within 24 hours after onset
Key inclusion criteria (3 listed)
- patients with septic shock
- at least one of the EGDT criteria not achieved
- informed consent accepted
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ICG-PDR and R15 before treatment, after EGDT and 24 hours after EGDT.
Time frame: 30 hours
1 secondary outcome
28 days mortality
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2014.
- Derived from this study: PubMed 27411453Zhang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Septic Shock, run by Zhongda Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaohua Qiu, MD (0086-025-83262553, xiaohua0917@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICG-PDR and R15 before treatment, after EGDT and 24 hours after EGDT. (time frame: 30 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02060773, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2014.