Shock, SepticNCT00335907
Protocol-driven Hemodynamic Support for Patients With Septic Shock
A study testing Fluid and Vasopressor Protocol in people with Shock, Septic and Severe Sepsis, run by National Institute of General Medical Sciences (NIGMS) at 1 site in United States.
Trial summary
This research is being done to see if a protocol (a set of orders that determine how much and how quickly a drug/fluid is given) for fluid and drugs used to increase blood pressure (vasopressors) will work better then general clinical practices to improve outcomes in patients with septic shock. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shock, Septic, Severe Sepsis, Sepsis
- What is being tested?
- Fluid and Vasopressor Protocol
- Type of treatment
- Surgery or procedure
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Jan 2011
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ACCP/SCCM sepsis criteria
- Need for institution of vasopressors after adequate volume resuscitation
Who cannot join
- Age< 18
- On vasopressors for > 24 hours prior to ICU admission
- Other cause for shock ( cardiac tamponade, massive pulmonary embolus, cardiogenic shock)
- Physicians and family not committed to aggressive medical therapy ( a patient will not be excluded if he/she would receive all care except for attempts at resuscitation from cardiac arrest)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
Jonathan E Sevransky, MD
About this study
This research is being done to see if a protocol (a set of orders that determine how much and how quickly a drug/fluid is given) for fluid and drugs used to increase blood pressure (vasopressors) will work better then general clinical practices to improve outcomes in patients with septic shock.
Read the detailed description
Septic shock is low blood pressure caused by an infection. Sepsis is the most common cause of death in non-cardiac intensive care units, and septic shock is the most severe form of sepsis. Treatment for septic shock includes giving antibiotics, intravenous fluids, and medications to raise the blood pressure (vasopressors).
We would like to see if a protocol-driven management strategy for septic shock can shorten time on vasopressors and limit the number of side effects. We have constructed a protocol that will allow the nurse at the bedside, in conjunction with the physician's orders, to adjust the amount of fluids and medications that raise the blood pressure (vasopressors).
- Conditions
- Shock, Septic, Severe Sepsis, Sepsis
- Being tested
- Fluid and Vasopressor Protocol
- Keywords
- Clinical trial, Controlled clinical trial, Shock, Septic
- Medical subject headings
- Shock, Septic, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluid and Vasopressor ProtocolProcedure or surgery
A Physician Ordered, Nurse Administered Fluid and Vasopressor Protocol
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of vasopressor treatment
Measured: within 90 days
Secondary outcomes (5)
Total number of vials vasopressors administered
Measured: Within 90 days
Time on more than single vasopressor
Measured: Within 90 days
Volume of intravenous fluids administered in first 7 days
Measured: 7 days
Number of organ failures
Measured: Within 90 days
ICU mortality rates
Measured: Within 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2006 (estimated)
- Study startSep 2006
- Primary completionJun 2010 (estimated)
- Study completionJan 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shock, SepticStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of General Medical Sciences (NIGMS)
- Sponsor type
- US National Institutes of Health
- Investigators
- Jonathan E Sevransky, MD, MHS, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00335907
- Sponsor's protocol ID
- K-23 NIGMS 2005
- Status last verified
- Aug 2010
- First submitted
- 9 Jun 2006
- Last updated
- 25 Aug 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol-driven Hemodynamic Support for Patients With Septic Shock
- ClinicalTrials.gov ID
- NCT00335907
- Acronym / sponsor ID
- K-23 NIGMS 2005
- Conditions
- Shock, Septic, Severe Sepsis, Sepsis
- Keywords
- Clinical trial, Controlled clinical trial, Shock, Septic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- National Institute of General Medical Sciences (NIGMS)US National Institutes of Health
- Study start
- Sep 2006
- Primary completion
- Jun 2010 (estimated)
- Study completion
- Jan 2011 (estimated)
- First posted
- 12 Jun 2006 (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.
This research is being done to see if a protocol (a set of orders that determine how much and how quickly a drug/fluid is given) for fluid and drugs used to increase blood pressure (vasopressors) will work better then general clinical practices to improve outcomes in patients with septic shock.
Detailed description
Septic shock is low blood pressure caused by an infection. Sepsis is the most common cause of death in non-cardiac intensive care units, and septic shock is the most severe form of sepsis. Treatment for septic shock includes giving antibiotics, intravenous fluids, and medications to raise the blood pressure (vasopressors).
We would like to see if a protocol-driven management strategy for septic shock can shorten time on vasopressors and limit the number of side effects. We have constructed a protocol that will allow the nurse at the bedside, in conjunction with the physician's orders, to adjust the amount of fluids and medications that raise the blood pressure (vasopressors).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ACCP/SCCM sepsis criteria
- Need for institution of vasopressors after adequate volume resuscitation
Key exclusion criteria (4 listed)
- Age< 18
- On vasopressors for > 24 hours prior to ICU admission
- Other cause for shock ( cardiac tamponade, massive pulmonary embolus, cardiogenic shock)
- Physicians and family not committed to aggressive medical therapy ( a patient will not be excluded if he/she would receive all care except for attempts at resuscitation from cardiac arrest)
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 |
|---|---|---|
| Fluid and Vasopressor ProtocolA Physician Ordered, Nurse Administered Fluid and Vasopressor Protocol | Procedure or surgery | – |
Primary outcome
Length of vasopressor treatment
Time frame: within 90 days
5 secondary outcomes
Total number of vials vasopressors administered
Time frame: Within 90 days
Time on more than single vasopressor
Time frame: Within 90 days
Volume of intravenous fluids administered in first 7 days
Time frame: 7 days
Number of organ failures
Time frame: Within 90 days
ICU mortality rates
Time frame: Within 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2010.
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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.
Jonathan E Sevransky, MD, MHS principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluid and Vasopressor Protocol in people with Shock, Septic and Severe Sepsis, run by National Institute of General Medical Sciences (NIGMS) at 1 site in United States.
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 2 inclusion and 4 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 25 Aug 2010. 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 United States. 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 Jonathan E Sevransky, MD (410-550-0546, jsevran1@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of vasopressor treatment (time frame: within 90 days). 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 25 Aug 2010.