SepsisPhase 4NCT00279214

Hemodynamic and Perfusion Response to Drotrecogin Alfa (Activated) in Patients With Septic Shock

A Phase 4 study testing drotrecogin alfa (activated) in people with Sepsis and Septic Shock, run by Eli Lilly and Company at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The study will evaluate the vasopressor requirement, hemodynamic response and measures of tissue perfusion in patients with septic shock receiving an infusion of drotrecogin alfa (activated) compared to patients not receiving drotrecogin alfa (activated). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Sepsis, Septic Shock
What is being tested?: drotrecogin alfa (activated)
How many people: 43 participants
Where: 2 sitesUnited States
Study dates: Nov 2005to Nov 2007
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

18 years of age or older with a diagnosis of septic shock
presence of a pulmonary artery catheter (or central venous catheters)
requiring vasopressor support despite adequate fluid resuscitation
an intravenous steroid administered for septic shock, except for those patients who were tested and are responders to a corticotropin stimulation test, or patients who do not receive a steroid due to the clinical judgment of the treating physician, based on an alternate assessment (e.g. normal baseline cortisol).

Who cannot join

Onset of first-sepsis induced organ dysfunction is greater than 24 hours from the time of informed consent
Baseline measurements of pulmonary artery occlusive pressure (PAOP) < 12 mmHg or a central venous pressure (CVP) < 8 mmHg
Patient requires continuous oxygen therapy by face-mask
The presence of an advanced directive to withhold life-sustaining treatment, with the exception of a directive to withhold chest compressions only
Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
Weight > 200 kg

Show all 9Show fewer

Are moribund (not expected to survive 24 hours)
Are pregnant or are lactating and the milk is to be ingested by the infant (pregnancy status must be verified by urine or serum testing)
Have not completed written informed consent signed by the patient or the patient's legal representative.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Akron, Ohio, 44307
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Camden, New Jersey, 08103

Other trials in United States

About this study

Official title: An Evaluation of Vasopressor Requirement, Hemodynamic Response and Measures of Tissue Perfusion With the Administration of Drotrecogin Alfa (Activated) as Part of Physician-Directed Therapy in Patients With Septic Shock

Conditions: Sepsis, Septic Shock
Being tested: drotrecogin alfa (activated)
Medical subject headings: Sepsis, Shock, Septic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

drotrecogin alfa (activated)Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

Cumulative Vasopressor Index (CVI)
CVI is sum of rankings for all vasopressors being used by patient at given time. Based on relative potency and dosing range for each vasopressor, each vasopressor was assigned ranking of 1 (low dosage) to 4 (high dosage). Range of CVI is between 1 and 20.
Measured: baseline to 24 hours

Secondary outcomes (10)

Change From Baseline to 96 Hour Endpoint in Cumulative Vasopressor Index (CVI)
CVI is sum of rankings for all vasopressors being used by patient at given time. Based on relative potency and dosing range for each vasopressor, each vasopressor was assigned ranking of 1 (low dosage) to 4 (high dosage). Range of CVI is between 1 and 20.
Measured: Baseline, 96 hours
Mean Arterial Pressure
Measured: baseline to 24 hours
Cardiovascular Performance Measures Obtained With a Pulmonary Artery Catheter - Cardiac Index
Cardiac Index = cardiac output divided by body surface area.
Measured: Baseline to 24 Hours
Lactate Level
Measures of global tissue perfusion and oxygenation were assessed via lactate levels.
Measured: Baseline to 6 Hours
Microcirculatory Measures From Sidestream Darkfield (SDF) Microscopy - Small Vessel Microvascular Flow Index (MFI)
Per vessel category (and per quadrant), scored flow as follows: no flow=0, intermediate flow=1, sluggish flow=2, continuous flow=3. The MFI per vessel category calculated with formula (Q1+Q2+Q3+Q4)/4. Scores could range from 0 (sluggish flow) to 3 (continuous flow).
Measured: Baseline to 24 Hours
Sequential Organ Failure Assessment (SOFA) Score at Baseline and 24 Hours
The presence of 5 organ dysfunctions (cardiovascular, respiratory, renal, hepatic, coagulation) was assessed using a Sequential Organ Failure Assessment (SOFA) score. Each organ has a possible dysfunction score of 0 to 4, for a total SOFA score range of 0 (no organ dysfunction) to 20 (all organs with dysfunction).
Measured: Baseline and 24 Hours
Change From Baseline in Creatinine Clearance (CrCl) at 24 Hours
CrCl = (urine creatinine*urine volume)/(plasma creatinine*time period of urine collection). Corrected CrCl = CrCl*1.73/body surface area. Change in CrCl = Endpoint minus baseline.
Measured: Baseline and 24 hours
7 Day All-cause In-hospital Mortality
Measured: baseline to 7 days
Endogenous Protein C Level
Measured: Baseline to 24 Hours
Mixed Venous Oxygen Saturation
Cardiovascular performance measures obtained with a pulmonary catheter as assessed by mixed venous oxygen saturation.
Measured: Baseline to 24 Hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2005Nov 2007

First posted19 Jan 2006 (estimated)
Study startNov 2005
Study completionNov 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for SepsisStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
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 4
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 43 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00279214
Sponsor's protocol ID: 9944
Other IDs: F1K-US-EVDA
Status last verified: Aug 2009
First submitted: 15 Dec 2005
Last updated: 2 Sep 2009
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
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Study at a glance

From the registry record, last updated by the sponsor on 2 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Evaluation of Vasopressor Requirement, Hemodynamic Response and Measures of Tissue Perfusion With the Administration of Drotrecogin Alfa (Activated) as Part of Physician-Directed Therapy in Patients With Septic Shock
ClinicalTrials.gov ID: NCT00279214
Acronym / sponsor ID: 9944
Conditions: Sepsis, Septic Shock
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 43 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Nov 2005
Study completion: Nov 2007 (actual)
First posted: 19 Jan 2006 (estimated)
Results: Posted 17 Aug 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-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 (4 listed)

18 years of age or older with a diagnosis of septic shock
presence of a pulmonary artery catheter (or central venous catheters)
requiring vasopressor support despite adequate fluid resuscitation
an intravenous steroid administered for septic shock, except for those patients who were tested and are responders to a corticotropin stimulation test, or patients who do not receive a steroid due to the clinical judgment of the treating physician, based on an alternate assessment (e.g. normal baseline cortisol).

Key exclusion criteria (9 listed)

Onset of first-sepsis induced organ dysfunction is greater than 24 hours from the time of informed consent
Baseline measurements of pulmonary artery occlusive pressure (PAOP) < 12 mmHg or a central venous pressure (CVP) < 8 mmHg
Patient requires continuous oxygen therapy by face-mask
The presence of an advanced directive to withhold life-sustaining treatment, with the exception of a directive to withhold chest compressions only
Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry

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
drotrecogin alfa (activated)	Drug	–

Primary outcome

Cumulative Vasopressor Index (CVI)
Time frame: baseline to 24 hours
CVI is sum of rankings for all vasopressors being used by patient at given time. Based on relative potency and dosing range for each vasopressor, each vasopressor was assigned ranking of 1 (low dosage) to 4 (high dosage). Range of CVI is between 1 and 20.

10 secondary outcomes

Change From Baseline to 96 Hour Endpoint in Cumulative Vasopressor Index (CVI)
Time frame: Baseline, 96 hours
Mean Arterial Pressure
Time frame: baseline to 24 hours
Cardiovascular Performance Measures Obtained With a Pulmonary Artery Catheter - Cardiac Index
Time frame: Baseline to 24 Hours
Lactate Level
Time frame: Baseline to 6 Hours
Microcirculatory Measures From Sidestream Darkfield (SDF) Microscopy - Small Vessel Microvascular Flow Index (MFI)
Time frame: Baseline to 24 Hours
Sequential Organ Failure Assessment (SOFA) Score at Baseline and 24 Hours
Time frame: Baseline and 24 Hours
Change From Baseline in Creatinine Clearance (CrCl) at 24 Hours
Time frame: Baseline and 24 hours
7 Day All-cause In-hospital Mortality
Time frame: baseline to 7 days
Endogenous Protein C Level
Time frame: Baseline to 24 Hours
Mixed Venous Oxygen Saturation
Time frame: Baseline to 24 Hours

Results and safety

Results posted to the registry on 17 Aug 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Drotrecogin Cohort	22	19
Control Cohort	21	19

Primary outcome: Cumulative Vasopressor Index (CVI)

Time frame: baseline to 24 hours. Mean (Standard Deviation). Unit: units on a scale

Measure	Drotrecogin Cohort n = 19	Control Cohort n = 19
24 Hour	2.3 (2.5)	3.0 (2.8)
24 Hour Change from Baseline	-2.0 (2.2)	-1.4 (2.2)

Drotrecogin Cohort vs Control Cohort: p = 0.238, Repeated Measures - propensity adjusted
Drotrecogin Cohort vs Control Cohort: p = 0.281, Repeated Measures - propensity adjusted

Population analysed: Number of per-protocol participants with values at baseline and 24 hours.

10 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Drotrecogin Cohort	4 of ?	4 of ?	Not reported
Control Cohort	3 of ?	0 of ?	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2009.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Lilly Clinical Trial RegistryLink provided by the sponsor.

Related trials for Sepsis

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CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
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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.

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-651-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director

Eli Lilly and Company

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing drotrecogin alfa (activated) in people with Sepsis and Septic Shock, run by Eli Lilly and Company at 2 sites 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 4 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: finished, as of the sponsor's last update on 2 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Aug 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Cumulative Vasopressor Index (CVI) (time frame: baseline to 24 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 NCT00279214.

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 2 Sep 2009; AzTrials last refreshed its copy on 7 Nov 2026.