Septic ShockNCT02706379
Impact of Early Goal-Directed Therapy to Perfusion and Metabolism of Brain
A study testing Local cerebral oxygen saturation in people with Septic Shock, run by Southeast University, China.
Trial summary
Early goal directed therapy (EGDT) is an effective treatment for patients with septic shock, which is widely used in clinic. Fluid resuscitation can significantly reduce the mortality of patients with septic shock and improve the prognosis of patients with EGDT. Read more about this study
- Who is it for?
- Ages 19 to 85 years
- Conditions the study is for
- Septic Shock
- What is being tested?
- Local cerebral oxygen saturation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Apr 2016
- Phase
- Interventional
- 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 19 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- New infectious shock in accordance with the diagnostic criteria of the 2012 SSC guidelines；
- Liquid recovery is not fully achieved EGDT standards, at least meet the following criteria:
- mean arterial pressure < 65mmHg
- central venous pressure < 8mmHg
- per hour urine volume was less than 0.5ml/kg
- central venous oxygen saturation <70%
- arterial blood lactic acid value > 2.5mmol/L
- Signed informed consent
Who cannot join
- Subjects/subjects client reject the invasive hemodynamic monitoring
- have contraindications to place hemodynamic monitoring
- unconsciousness state before septic shock and GCS<12
- cannot put the electrodes on the eyebrow
- pregnant or lactating women
- end stage of illness or death rate is more than 80%
About this study
Official title: The Impact of Early Goal-Directed Therapy to Perfusion and Metabolism of Brain in Septic Shock Patients
Early goal directed therapy (EGDT) is an effective treatment for patients with septic shock, which is widely used in clinic. Fluid resuscitation can significantly reduce the mortality of patients with septic shock and improve the prognosis of patients with EGDT. However, in recent years, the standard of EGDT to determine the existence of the target of septic shock. Some studies have shown that there may be a manifestation of the deficiency of kidney and liver and other organs such as kidney, liver and other organs in the recovery of EGDT. Therefore, this experiment is to explore the brain perfusion and metabolism of the EGDT when the target is reached.The aim of this study was to investigate the effects of EGDT as a guide to the cerebral perfusion and metabolism in order to provide clinical evidence for the treatment of fluid resuscitation in patients with septic shock.
Read the detailed description
- patients enrollment this project: Met the inclusion criteria without exclusion criteria were entered test, and record the general information, including name, hospital number, gender, age, height, weight, admission, and in time, ICU admission and in ICU diagnosis, previous underlying diseases, into the group of APACHE II score and SOFA score
- implement septic shock bundle: measurement the value of lactic acid of patients after administrating of ICU, take blood culture before antibiotic using, give wide-spectrum antibiotic treatment and began liquid resuscitation
- preparation： A. basic state records B. using CAM-ICU delirium assessment for patients, and record the assessment results C. cerebral oxygen saturation monitor D. via the jugular vein placed central venous catheter and femoral artery placed PiCCO catheter
- monitoring of hemodynamics and cerebral perfusion and metabolic indicators
- Conditions
- Septic Shock
- Being tested
- Local cerebral oxygen saturation
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local cerebral oxygen saturationOther
take blood culture before antibiotic use;measure the blood lactate;liquid rescisutation as 20ml/kg
| Study group | Role | What they receive |
|---|---|---|
| Local cerebral oxygen saturation | Experimental | use NIRS technical to detect local cerebral oxygen saturation of both sides of brain Receives: Other: Local cerebral oxygen saturation |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of local cerebral oxygen saturation between early goal directed treatment(EGDT)
Test the local cerebral oxygen saturation of both sides of brain through near infrared spectroscopy technology. And record the change of local cerebral oxygen of the left and right's brain.
Measured: through study completion, up to 6 hours
Secondary outcomes (2)
change of neuron specific enolase(NSE)
NSE is an enzyme that in humans is encoded by the ENO2 gene. NSE is produced by small cell carcinomas which are neuroendocrine in origin, and the raise of its concentration indicates the injury of brain.
Measured: through study completion, up to 6 hours
change of S-100 protein
S-100 protein S100 proteins are normally present in cells derived from the neural crest (Schwann cells, and melanocytes), chondrocytes, adipocytes, myoepithelial cells, macrophages, Langerhans cells, dendritic cells, and keratinocytes.S100 proteins have been implicated in a variety of intracellular and extracellular functions.
Measured: through study completion, up to 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2016 (estimated)
- Study startJun 2015
- Primary completionApr 2016 (estimated)
- Study completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jingyuan,Xu, Southeast University, China
- Investigators
- Haibo Qiu, Doctor, Study director, 13951965301
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02706379
- Sponsor's protocol ID
- 2015ZDSYLL036.0
- Status last verified
- Feb 2016
- First submitted
- 11 Dec 2015
- Last updated
- 11 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: The data is personal, and will not share to others.
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Early Goal-Directed Therapy to Perfusion and Metabolism of Brain in Septic Shock Patients
- ClinicalTrials.gov ID
- NCT02706379
- Acronym / sponsor ID
- 2015ZDSYLL036.0
- Conditions
- Septic Shock
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 11 Mar 2016 (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.
Early goal directed therapy (EGDT) is an effective treatment for patients with septic shock, which is widely used in clinic. Fluid resuscitation can significantly reduce the mortality of patients with septic shock and improve the prognosis of patients with EGDT. However, in recent years, the standard of EGDT to determine the existence of the target of septic shock. Some studies have shown that there may be a manifestation of the deficiency of kidney and liver and other organs such as kidney, liver and other organs in the recovery of EGDT. Therefore, this experiment is to explore the brain perfusion and metabolism of the EGDT when the target is reached.The aim of this study was to investigate the effects of EGDT as a guide to the cerebral perfusion and metabolism in order to provide clinical evidence for the treatment of fluid resuscitation in patients with septic shock.
Detailed description
- patients enrollment this project: Met the inclusion criteria without exclusion criteria were entered test, and record the general information, including name, hospital number, gender, age, height, weight, admission, and in time, ICU admission and in ICU diagnosis, previous underlying diseases, into the group of APACHE II score and SOFA score
- implement septic shock bundle: measurement the value of lactic acid of patients after administrating of ICU, take blood culture before antibiotic using, give wide-spectrum antibiotic treatment and began liquid resuscitation
- preparation： A. basic state records B. using CAM-ICU delirium assessment for patients, and record the assessment results C. cerebral oxygen saturation monitor D. via the jugular vein placed central venous catheter and femoral artery placed PiCCO catheter
- monitoring of hemodynamics and cerebral perfusion and metabolic indicators
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Local cerebral oxygen saturation | Experimental | Other: Local cerebral oxygen saturationuse NIRS technical to detect local cerebral oxygen saturation of both sides of brain |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- New infectious shock in accordance with the diagnostic criteria of the 2012 SSC guidelines；
- Liquid recovery is not fully achieved EGDT standards, at least meet the following criteria:
- Signed informed consent
Key exclusion criteria (6 listed)
- Subjects/subjects client reject the invasive hemodynamic monitoring
- have contraindications to place hemodynamic monitoring
- unconsciousness state before septic shock and GCS<12
- cannot put the electrodes on the eyebrow
- pregnant or lactating women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Local cerebral oxygen saturationtake blood culture before antibiotic use;measure the blood lactate;liquid rescisutation as 20ml/kg | Other | Local cerebral oxygen saturation |
Primary outcome
change of local cerebral oxygen saturation between early goal directed treatment(EGDT)
Time frame: through study completion, up to 6 hours
Test the local cerebral oxygen saturation of both sides of brain through near infrared spectroscopy technology. And record the change of local cerebral oxygen of the left and right's brain.
2 secondary outcomes
change of neuron specific enolase(NSE)
Time frame: through study completion, up to 6 hours
change of S-100 protein
Time frame: through study completion, up to 6 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2016.
- Individual participant dataSharing planned: No. The data is personal, and will not share to others.
Related trials for Septic Shock
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ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
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Longitudinal Trajectories of Myocardial Work in Patients With Sepsis
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Sepsis
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.
Haibo Qiu, Doctor study director
13951965301
Questions about this trial
What is this clinical trial studying?
A study testing Local cerebral oxygen saturation in people with Septic Shock, run by Southeast University, 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 8 inclusion and 6 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 11 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of local cerebral oxygen saturation between early goal directed treatment(EGDT) (time frame: through study completion, up to 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Mar 2016.