FAQs List:

Injuries and some reactions to medications can cause the kidneys to fail very quickly. Losing a lot of blood can cause sudden kidney failure. This sudden drop in kidney function can be called “acute kidney injury” (AKI) or “acute renal failure”(AKF). AKI may lead to permanent loss of kidney function, but if the kidneys are not seriously damaged, complete recovery may occur.

Most kidney problems occur slowly, and a person may have “silent” kidney disease for years. The ongoing loss of kidney function is called chronic kidney disease (CKD). The kidneys filter waste and excess fluids from the blood which are then excreted in urine. When chronic kidney failure damages the kidneys, dangerous levels of fluid and waste can accumulate in the body, and loss of kidney function can occur over time leading to chronic kidney disease. AKI may lead to CKD.

Sepsis is a condition in which the body is fighting a severe infection that has spread through the bloodstream. If a patient becomes "septic," they will likely have low blood pressure leading to poor circulation and lack of blood flow to important tissues and organs. Septic shock can develop either as a result of the body's own defense system, or from toxic substances such as a bacteria, virus, or fungus. While sepsis can occur in people of any age, it is more common in infants, older adults, and people who have compromised immune systems. Sepsis is usually treated in a hospital intensive care unit (ICU). IV antibiotics and fluids may be given to try to cure the infection, and to keep blood pressure from dropping too low.

The Protocolized Goal-directed Resuscitation of Septic Shock to Prevent AKI (ProGReSS AKI) is a long term follow up study on subjects who were hospitalized at a participating hospital for the study called Protocolized Care for Early Septic Shock (ProCESS). While several in-hospital measurements are being collected within the ProCESS study, ProGReSS AKI intends to follow ProCESS subjects after hospital discharge to better understand the long-term consequences of sepsis. Researchers will focus on two important complications: recovery of renal function and cardiovascular consequences. ProGReSS AKI will include in hospital blood and urine collection, and four in-home study visits over the course of three years. This study will help researches determine if a subject’s treatment plan assigned in ProCESS was more effective on improving long term outcomes such as survival, renal recovery, and a reduced progression of chronic kidney disease (CKD).

This study is being conducted by the CRISMA Center located within the Department of Critical Care Medicine at the University of Pittsburgh.

The ProGReSS AKI study is supported by the National Institutes of Health funded by Award Number R01DK083961 though the National Institute of Diabetes and Digestive and Kidney Diseases.

This study is scheduled to start enrolling in 2011 and the active enrollment period for the 300-400 subjects is currently 36 months.

Only the subjects who were previously enrolled in the study Protocolized Care for Early Septic Shock (ProCESS) can be enrolled in ProGReSS AKI

Subjects who give their permission to participate in ProGReSS AKI will receive in-home study visits from a health professional. Once the ProGReSS AKI coordinating center receives a subject's consent, we will arrange to conduct a subject’s in-home study visit. We will be using trained paramedical professionals, who have been certified to conduct insurance physicals and the collection of blood samples.

In-home study visits will consist of:

• A physical examination measuring height, weight, blood pressure, pulse and assessment of peripheral edema or swelling from fluid buildup in lower extremities (legs and feet).


• A detailed medical history interview with questions regarding tobacco use, alcohol consumption, and drug use. Also, a questionnaire that will focus on: lifestyle and sleeping habits, medications, recent illness and hospitalizations, heart and kidney symptoms.


• A small collection of blood (approximately 4 teaspoons) and urine (approximately 2 tablespoons)

ProGReSS AKI is an observational study meaning that subjects will not be given experimental treatments. Thus the risks to subjects are extremely low and limited to the risks associated with the blood draws such as bleeding, infection, bruising and discomfort at the injection site. These risks will be minimized by having a trained paramedical professional with phlebotomy (blood drawl) experience draw blood samples. All information collected as part of study will stored in a password protected, secure database where only the study team will have access.

A direct benefit of participation in this study will be free in home medical exams and lab testing. If lab testing of blood and urine samples show evidence of kidney disease, a referral will be sent to the subject’s Primary Care Physician (PCP) recommending follow up medical evaluation.