Talking with the Treatment Team

If your loved one has been diagnosed with severe sepsis, you no doubt want to maintain close communication with the treatment team. Here, you can find answers to some questions you may have about talking to the treatment team, including:

Who takes care of patients with severe sepsis?
What role can you play in treatment?
What's the best way to communicate with the ICU doctors and nurses?
What specific questions should you ask the ICU doctors and nurses?

Who takes care of patients with severe sepsis?

A patient with severe sepsis will often be treated in a hospital's emergency department and ICU (Intensive Care Unit) because his or her condition can worsen very quickly. Treatment may involve several types of healthcare professionals, including:

Emergency department staff — often the first doctors and nurses to encounter severe sepsis. (Patients are commonly transferred to the ICU for further treatment)
Critical care doctors — ICU doctors who are trained to recognize and treat critically ill patients, including those with severe sepsis
Critical care nurses — ICU nurses who are specially trained to care for critically ill patients, including those with severe sepsis
Infectious disease (ID) doctors — specialists who help decide which antibiotics to give to a patient in order to fight infection. They have specific knowledge about the various "germs" that cause severe sepsis
Surgeons — if a patient is in the hospital for surgery and gets severe sepsis, the surgeon often helps make decisions about his or her care. Sometimes a surgeon will operate on a patient to remove the source of infection

What role can you play in treatment?

When someone you care about has severe sepsis, you can help yourself and your family member or friend by learning as much as you can about the illness. This will help you understand the condition and how it is treated. Begin by visiting websites such as:

In addition, here are some tips that will help you help your loved one:

Ask questions of your loved one's doctors and nurses
Make sure you understand the nature and seriousness of your loved one's condition
Support your loved one's wishes — particularly regarding the types of treatments they would want
Understand why certain treatments are being given and understand the benefits and risks

What's the best way to communicate with the ICU doctors and nurses?

ICU doctors and nurses are valuable sources of information. Sometimes, the ICU staff will ask a patient's family to choose a spokesperson. This spokesperson serves as an advocate for the patient, asking questions when the patient is admitted and throughout the patient's stay. Having a single source of communication helps everyone get the same information quickly.

If your family chooses a spokesperson, have him or her ask the doctor or nurse questions from your family that will help you make better decisions about the patient's care. For general questions about severe sepsis or the types of treatments a patient is getting, have your spokesperson ask the doctor or nurse to suggest other sources of information, or visit websites such as this one and others listed on this site

What specific questions should you ask the ICU doctors and nurses?

Here are some key questions you or your family's spokesperson should ask:

How serious is the illness?
How many organs are shutting down (lungs, kidneys, etc.)?
Is the patient getting better or worse, or are they unchanged? How can you tell?
What treatments are you currently giving? What do they do?
Is the patient on medication to raise blood pressure (vasopressors)?
What else can you do to give them a better chance of surviving?
Could Xigris (pronounced "zy-gris") help the patient?

IMPORTANT SAFETY INFORMATION

Xigris is indicated for the reduction of mortality in adult patients with severe sepsis (sepsis associated with acute organ dysfunction) who have a high risk of death (eg, as determined by APACHE II*).

Xigris is not indicated in adult patients with severe sepsis and lower risk of death. Xigris is not indicated in pediatric patients with severe sepsis.

CONTRAINDICATIONS

Xigris increases the risk of bleeding. Xigris is contraindicated in patients with the following clinical situations in which bleeding could be associated with a high risk of death or significant morbidity:

Active internal bleeding
Recent (within 3 months) hemorrhagic stroke
Recent (within 2 months) intracranial or intraspinal surgery, or severe head trauma
Trauma with an increased risk of life-threatening bleeding
Presence of an epidural catheter
Intracranial neoplasm or mass lesion or evidence of cerebral herniation

Xigris is contraindicated in patients with known hypersensitivity to drotrecogin alfa (activated) or any component of this product.

WARNINGS

Bleeding

Bleeding is the most common serious adverse effect associated with Xigris therapy. Each patient being considered for therapy with Xigris should be carefully evaluated and anticipated benefits weighed against potential risks associated with therapy.

Certain conditions, many of which led to exclusion from the Phase 3 trial, are likely to increase the risk of bleeding with Xigris therapy. Therefore, for patients with severe sepsis who have one or more of the following conditions, the increased risk of bleeding should be carefully considered when deciding whether to use Xigris therapy:

Concurrent therapeutic heparin to treat an active thrombotic or embolic event
Platelet count <30,000 x 10⁶/L, even if the platelet count is increased after transfusions
Prothrombin time-INR >3.0
Recent (within 6 weeks) gastrointestinal bleeding
Recent administration (within 3 days) of thrombolytic therapy
Recent administration (within 7 days) of oral anticoagulants or glycoprotein IIb/IIIa inhibitors
Recent administration (within 7 days) of aspirin >650 mg per day or other platelet inhibitors
Recent (within 3 months) ischemic stroke
Intracranial arteriovenous malformation or aneurysm
Known bleeding diathesis
Chronic severe hepatic disease
Any other condition in which bleeding constitutes a significant hazard or would be particularly difficult to manage because of its location

Invasive procedures increase the risk of bleeding among patients receiving Xigris. Xigris should be discontinued prior to the performance of invasive surgical procedures or other procedures associated with special risks for bleeding.

Mortality in patients with single organ dysfunction and recent surgery

Among the small number of patients enrolled in PROWESS with single organ dysfunction and recent surgery (surgery within 30 days prior to study treatment) all-cause mortality was numerically higher in the Xigris group (28-day: 10/49; in-hospital: 14/48) compared to the placebo group (28-day: 8/49; in-hospital: 8/47).

In an analysis of the subset of patients with single organ dysfunction and recent surgery from a separate, randomized, placebo-controlled study (ADDRESS) of septic patients not at high risk of death all-cause mortality was also higher in the Xigris group (28-day: 67/323; in-hospital: 76/325) compared to the placebo group (28-day: 44/313; in-hospital: 62/314). Patients with single organ dysfunction and recent surgery may not be at high risk of death irrespective of APACHE II score and therefore not among the indicated population.

Clinicians should consider continuing prophylactic heparin when initiating Xigris therapy, unless discontinuation is considered medically necessary

In a randomized study of prophylactic heparin versus placebo in 1935 adult severe sepsis patients treated with Xigris, mortality and the rate of serious adverse events were increased in the subgroup of 434 patients whose low-dose heparin was stopped on study entry by randomization to placebo. This finding was based on prospectively defined exploratory subgroup analyses; however, the explanation for the finding is unclear.

ADVERSE REACTIONS

Bleeding is the most common adverse reaction associated with Xigris therapy. In the Phase 3 study, serious bleeding events were observed during the 28-day study period in 3.5% of Xigris-treated and 2.0% of placebo-treated patients. The difference in serious bleeding occurred primarily during infusion. The incidence of intracranial hemorrhage (ICH) was 0.2% for Xigris-treated and 0.1% for placebo-treated patients. ICH has been reported in Xigris-treated patients in non-placebo controlled trials with an incidence of approximately 1% during infusion. The risk of ICH may be increased in patients with risk factors for bleeding such as severe coagulopathy and severe thrombocytopenia. Should clinically important bleeding occur, immediately stop the Xigris infusion.

*APACHE (Acute Physiology And Chronic Health Evaluation).

Please refer to the full Prescribing Information for Xigris.