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Study Comparing Intravenous Contrast CT with Non-Contrast CT for Patients with Acute Abdominal Pain and Reduced Kidney Function Using Iohexol

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on patients experiencing an acute abdomen, which refers to sudden and severe abdominal pain that may require urgent medical attention. The study is particularly interested in patients who also have impaired renal function, meaning their kidneys are not working as well as they should. The trial will compare two types of computed tomography (CT) scans: one using an intravenous (IV) contrast called Omnipaque, which contains the active substance iohexol, and the other without any contrast.

The purpose of the study is to determine if using the IV contrast CT is better at diagnosing the cause of acute abdomen in these patients compared to a CT scan without contrast. Participants will be randomly assigned to receive either the contrast-enhanced CT or the non-contrast CT. The study will monitor participants for up to 90 days to observe outcomes such as overall survival, the need for kidney support treatments, and any changes in kidney function.

Throughout the study, researchers will also look at other factors, such as the severity of any acute kidney injury (AKI)</b) that might occur, any organ dysfunction, and the number of days participants spend out of the hospital. The study aims to provide valuable information on the best imaging approach for patients with acute abdomen and impaired kidney function, potentially improving diagnosis and treatment strategies in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be informed about the purpose and procedures involved. This study aims to compare two types of computed tomography (CT) scans for patients with acute abdominal issues and reduced kidney function.
Step 2
Randomization
You will be randomly assigned to one of two groups. One group will receive a CT scan with intravenous (IV) contrast, and the other will receive a CT scan without contrast. This process is random to ensure unbiased results.
Step 3
CT scan procedure
If you are in the group receiving the IV contrast, you will be given a solution called Omnipaque 350 mg I/ml through an injection or infusion. This helps to improve the clarity of the CT images. The dosage and administration will be determined by the medical team based on your specific needs.
Step 4
Monitoring after CT scan
After the CT scan, your kidney function will be monitored. This involves checking your blood for creatinine levels within 72 hours to assess any changes in kidney function. Creatinine is a waste product that the kidneys usually filter out of the blood.
Step 5
Follow-up period
You will be observed for up to 90 days after the CT scan. During this time, the study will track your overall health, including any need for kidney support treatments and your recovery progress.

Who can join the trial?
4 criteria

Patients who need an emergency CT scan of the abdomen or body.
Patients with an eGFR (a measure of kidney function) between 15-45 ml/min/1.73 m². This is calculated from the most recent blood test for creatinine, done within 24 hours before joining the study.
Both men and women can participate.
Participants can be from vulnerable populations, which means they might need extra protection or care.

Who cannot join the trial?
1 criterion

Patients who need an emergency CT scan of the abdomen or body and have an eGFR (a measure of kidney function) between 15-45 ml/min/1.73 m² cannot participate. The eGFR is calculated from the most recent blood test taken within 24 hours before joining the study.

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Verified sites
All sites with verified contact details – recruitment status may not be available; ask directly
Akershus University Hospital
Verified
Lorenskog, Norway
Helsinki University Central Hospital
Verified
Helsinki, Finland
Oslo Universitetssykehus HF
Verified
Oslo, Norway
Trial locations
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Investigated drugs

Intravenous Contrast is a special dye used in medical imaging to help doctors see the inside of your body more clearly. In this trial, it is used during a CT scan to provide a better view of the organs and tissues in your abdomen. This helps doctors make a more accurate diagnosis of any issues you might have. The contrast is given through a vein, usually in your arm, and it travels through your bloodstream to highlight certain areas in the images taken by the CT scan.

Iohexol

What is already known about the treatment

Intravenous Contrast Agent – This medication is administered through an injection into a vein, allowing it to travel through the bloodstream. It is currently being studied in clinical trials to determine its effectiveness in improving the diagnosis of acute abdominal conditions in patients with reduced kidney function. The main therapeutic use of this agent is to enhance the clarity of CT scans, making it easier for doctors to identify issues within the abdomen. At the molecular level, the contrast agent works by altering the way X-rays interact with the body, providing a clearer image of internal structures. It is classified as a diagnostic imaging agent.

Investigated diseases

Acute Kidney Injury – Acute Kidney Injury (AKI) is a sudden episode of kidney failure or kidney damage that happens within a few hours or a few days. It causes waste products to build up in the blood and makes it hard for the kidneys to maintain the right balance of fluid in the body. AKI can occur due to various reasons, including reduced blood flow to the kidneys, direct damage to the kidneys, or blockage of the urinary tract. The condition can lead to a decrease in urine output, swelling due to fluid retention, and fatigue. As the kidneys fail to filter waste effectively, it can result in an accumulation of toxins in the body. AKI can progress rapidly, requiring immediate medical attention to prevent further complications.