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Completed

NCT Number: NCT00279214

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

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).

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Key information

Conditions

Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Septic Shock Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion:

  • 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).

Exclusion:

  • 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
  • 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.

Treatment and study plan

Drotrecogin Alfa (Activated)

Drug

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change From Baseline to 96 Hour Endpoint in Cumulative Vasopressor Index (CVI)

    Time frame: Baseline, 96 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.

  2. Mean Arterial Pressure

    Time frame: baseline to 24 hours

  3. Cardiovascular Performance Measures Obtained With a Pulmonary Artery Catheter - Cardiac Index

    Time frame: Baseline to 24 Hours

    Cardiac Index = cardiac output divided by body surface area.

  4. Lactate Level

    Time frame: Baseline to 6 Hours

    Measures of global tissue perfusion and oxygenation were assessed via lactate levels.

  5. Microcirculatory Measures From Sidestream Darkfield (SDF) Microscopy - Small Vessel Microvascular Flow Index (MFI)

    Time frame: Baseline to 24 Hours

    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).

  6. Sequential Organ Failure Assessment (SOFA) Score at Baseline and 24 Hours

    Time frame: 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).

  7. Change From Baseline in Creatinine Clearance (CrCl) at 24 Hours

    Time frame: Baseline and 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.

  8. 7 Day All-cause In-hospital Mortality

    Time frame: baseline to 7 days

  9. Endogenous Protein C Level

    Time frame: Baseline to 24 Hours

  10. Mixed Venous Oxygen Saturation

    Time frame: Baseline to 24 Hours

    Cardiovascular performance measures obtained with a pulmonary catheter as assessed by mixed venous oxygen saturation.

Other outcomes

  1. Number of Participants With Bleeding Events

    Time frame: baseline to 7 days

    Serious bleeding event resulted in one of following outcomes, or was significant for any reason: initial/ prolonged inpatient hospitalization; life-threatening experience; persistent or significant disability/incapacity; congenital anomaly/birth defect. Intracranial hemorrhage was also considered serious bleeding event.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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

Important dates

Study start
2005
Study completion
2007
First posted
Jan 19, 2006
Registry last updated
Sep 2, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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