Impact of a treatment with angiotensin receptor blocker on outcome after acute kidney injury in patients discharged from the ICU “START-or-NOT” trial. A prospective, randomized, double blinded, multicenter study
Acute kidney injury is sudden damage that stops the kidneys from filtering blood properly. It commonly affects people who become very ill in intensive care units (ICU). Even after leaving hospital, patients who had kidney injury have a higher chance of developing heart problems, stroke, or lasting kidney damage. This trial, called START-or-NOT, tests whether a tablet called irbesartan can help. Irbesartan is already widely used for high blood pressure and kidney protection. In this study, half of the participants receive irbesartan and half receive an identical dummy pill (placebo) for one year after leaving intensive care. Doctors will track both groups to see if irbesartan reduces serious heart complications and keeps the kidneys working well. The findings could help doctors improve long-term care and protect the health of people recovering from severe illness.
At a glance
What is this study about?
When people are treated in an intensive care unit (ICU), severe illness can put heavy stress on the body. A common complication is acute kidney injury, where the kidneys suddenly struggle to filter waste and fluid from the blood. Although many patients recover enough to leave intensive care, the kidneys may remain vulnerable. In the months after discharge, these patients face an increased risk of long-term kidney disease, high blood pressure, heart attacks, and strokes.
Doctors are searching for reliable ways to protect both the kidneys and the heart during recovery. This trial is studying a medicine called irbesartan. Irbesartan belongs to a well-known family of medications that relax blood vessels and lower blood pressure. In routine medical care, it is often prescribed to shield the kidneys from damage caused by conditions like diabetes or high blood pressure.
In this study, researchers want to find out whether starting irbesartan soon after leaving intensive care helps prevent future hospital visits for heart problems or stroke. They also want to check whether it prevents permanent kidney damage, reduces protein leaks in the urine, and keeps kidney function stable over the course of a full year.
Because this is a phase III clinical trial, it aims to provide clear, definitive evidence. If irbesartan proves effective, it could become a standard treatment to help people stay healthier and out of hospital after a critical illness.
Key takeaways
- Tests whether a daily tablet (irbesartan) protects the heart and kidneys after a stay in intensive care.
- Aimed at adults recovering from sudden kidney damage (acute kidney injury).
- Compares the active medicine against a dummy pill (placebo) over 12 months.
- Involves regular health reviews, blood pressure checks, and routine blood tests.
- Taking part is completely voluntary and will not change your right to standard medical care.
Who may be eligible?
This trial is open to adults aged 18 and older who were treated in an intensive care unit (ICU) or a transitional care unit (step-down ward) and had acute kidney injury during their hospital stay.
Both men and women can take part. However, because irbesartan affects blood pressure and kidney chemistry, the treatment may not be suitable for everyone. For instance, people with very low blood pressure, severe ongoing kidney failure, or unusually high potassium levels in their blood may not be able to join.
A doctor on the study team will carefully review your recent blood test results, medical history, and current medications to make sure that taking part is completely safe for you.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- You are aged 18 or older.
- You have recently stayed in an intensive care or transitional care unit.
- You were diagnosed with sudden kidney injury during your hospital stay.
- You are being discharged or have recently been discharged from the unit.
- You are able to swallow a daily tablet and attend check-ups for one year.
What does participation involve?
If you take part, your involvement will last for about one year after you leave intensive care. You will be randomly chosen by a computer to receive either irbesartan tablets (150 mg) or matching dummy tablets (placebo). Neither you nor your doctor will know which tablet you are taking, which ensures the test remains completely fair. You will take one tablet by mouth each day. During the year, you will have regular check-ups, which are often arranged to fit in with your normal hospital follow-up visits. At these appointments, the medical team will check your blood pressure, ask how you are feeling, and take routine blood and urine samples to monitor your kidneys and potassium levels. The team will also record if you need any hospital treatment during the year.
Potential risks and benefits
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Common questions
What is acute kidney injury?
Acute kidney injury is a sudden drop in how well the kidneys work. It often happens during severe illness and can usually improve, but it leaves the kidneys delicate and needs careful follow-up.
What is a placebo?
A placebo is a dummy tablet that looks identical to the real medicine but contains no active ingredients. It helps researchers prove whether any health improvements are truly caused by the study drug.
Can I choose whether I get irbesartan or the placebo?
No. A computer assigns you to a group by chance. This random process ensures the study results are trustworthy and fair.
What happens if I experience side effects?
You will have a direct contact number for the research team. If you feel unwell or tests show any concerns, the study doctor can adjust your care or stop the medication immediately.
Will taking part affect my usual prescriptions?
The trial team will look closely at all your medications to ensure the study tablet does not interfere with any treatments you already take.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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