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High-dose insulin lispro, potassium chloride and glucose treatment for patients with non‑toxic acute cardiogenic shock

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What is this trial about?

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

The trial examines Non-toxic acute cardiogenic shock, a sudden failure of the heart to pump enough blood when no poison is involved. The investigational approach is high-dose insulin euglycemic therapy, which delivers a large amount of insulin lispro through an IV together with potassium chloride and glucose to keep blood sugar in a safe range while supporting the heart’s pumping ability.

The purpose of the study is to determine whether this therapy improves heart performance and is safe compared with standard care. Participants are randomly assigned to receive either the insulin‑based regimen plus usual treatment or usual treatment alone. The study treatment is given for up to two days while patients remain in the hospital, during which doctors watch heart function, blood pressure, kidney function and any side effects using a thin tube called a catheter (via pulmonary artery catheterization) and regular blood tests. After leaving the hospital, patients are checked again for about six weeks to see if they needed extra heart‑support devices and how well the heart and kidneys are working.

Safety monitoring includes continuous observation of heart rhythm, blood pressure, and the amounts of other heart‑support medicines used. The trial is open label, meaning both the care team and the participants know which treatment is being given, and it is designed as a small pilot to gather early information about the new approach.

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
Enrollment and baseline assessment
After joining the trial, baseline data are collected, including heart function measurements, blood tests, and insertion of a pulmonary artery catheter for continuous monitoring.
Baseline values for cardiac output, blood pressure, heart rate, kidney function, and blood glucose are recorded.
Step 2
Start of infusion therapy
The study treatment begins with a continuous infusion of insulin lispro at a total dose of 24000 iu (international units).
Simultaneously, potassium chloride is infused at a total amount of 750 units to maintain normal potassium levels.
A 50% glucose solution is infused at a total volume of 2000 ml to keep blood sugar within the target range.
All three solutions are administered through intravenous lines and are adjusted as needed based on frequent laboratory results.
Step 3
Continuous monitoring
Heart function is monitored continuously with the pulmonary artery catheter, recording cardiac output, pulmonary vascular resistance, mixed venous oxygen saturation, and other parameters.
Blood glucose and potassium levels are checked regularly, and the infusion rates of insulin, potassium chloride, and glucose are modified to maintain target ranges.
Electrocardiogram monitoring detects any arrhythmias, and urine output is measured to assess kidney function.
Standard treatments for non‑toxic acute cardiogenic shock are continued alongside the study medication.
Step 4
48‑hour evaluation
After 48 hours, the primary assessments are performed.
Changes from baseline are recorded for cardiac output, pulmonary vascular resistance, mixed venous oxygen saturation, lactate, and nt‑probnp.
Echocardiographic measurements of left ventricular ejection fraction, left ventricular outflow tract velocity time integral, and e/e’ are obtained.
Kidney function is evaluated using estimated glomerular filtration rate, plasma urea, and urine output.
Heart rate, mean arterial pressure, and the sequential organ failure assessment score are documented.
Any arrhythmias and the total dose of vasoactive, inotropic, and diuretic drugs used are noted.
Step 5
Follow‑up at 6 weeks
Participants are assessed again at six weeks after enrollment.
The primary long‑term outcomes include survival without the need for mechanical circulatory support, left ventricular ejection fraction measured by echocardiography, and kidney function evaluated by eGFR and plasma urea.

Who can join the trial?

7 criteria

Must be an adult (18 years or older) patient.
Must have non‑toxic acute cardiogenic shock, which means the heart is not pumping enough blood without a poisonous cause.
Must meet the SCAI classification C, D, or E, a grading system that defines classic cardiogenic shock.
Must have a systolic blood pressure (the top number in a blood pressure reading) lower than 90 mmHg for more than 30 minutes even after receiving fluid treatment.
Must show clinical or laboratory evidence of end‑organ damage, indicating that vital organs such as the kidneys, liver, or brain are being affected.
Both men and women are eligible to participate.
The study allows participation of vulnerable individuals, provided all other criteria are met.

Who cannot join the trial?

9 criteria

Having a heart shock caused by an overdose of beta‑blocker or calcium‑channel blocker medicines.
Having acute coronary syndrome (a sudden problem with the heart’s blood supply, such as a heart attack).
Having myocarditis (inflammation of the heart muscle).
Having cardiac tamponade (pressure on the heart from fluid that builds up around it).
Having a pulmonary embolism (a blood clot that blocks an artery in the lungs).
Being unable to have a pulmonary artery catheter (PAC) placed for monitoring.
Being unable to give informed consent (not able to agree to take part after understanding the study).
Already taking part in another clinical trial at the same time.
Having a known allergy to insulin lispro or any of its inactive ingredients.

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Oslo Universitetssykehus HF
Oslo, Norway

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Investigated drugs

Insulin lispro
is a fast‑acting form of insulin that helps lower blood sugar quickly. In this trial it is given through an IV to provide a strong, controlled drop in blood glucose, which can support heart function during severe shock.
Potassium chloride
is a mineral solution that adds potassium to the blood. Potassium is important for keeping the heart’s electrical activity stable. In the study it is infused to prevent low potassium levels that can occur when high doses of insulin are used.
Glucose solution (50% dextrose)
is a concentrated sugar fluid given through an IV. It raises blood sugar to counteract the lowering effect of the insulin, helping keep the patient’s blood glucose at a safe level while the insulin works on the heart.
High‑dose Insulin Euglycemic Therapy (HIET)
is the overall treatment strategy that combines the fast‑acting insulin, the glucose solution, and the potassium chloride. The goal is to improve heart pumping ability and blood pressure in patients with severe, non‑toxic cardiogenic shock while carefully maintaining normal blood sugar and electrolyte balance.

What is already known about the treatment

Insulin lispro
This rapid‑acting insulin is given by intravenous infusion as a clear solution for injection. It is an approved, widely used medication for diabetes and is also studied for high‑dose insulin therapy in cardiogenic shock. It works by attaching to insulin receptors, helping cells take up glucose and lowering blood sugar levels. It belongs to the class of rapid‑acting insulins, a type of antidiabetic drug.
Potassium chloride
This electrolyte is supplied as a concentrate for intravenous infusion, mixed with fluid before use. It is a standard, approved treatment for low potassium levels and helps keep heart and muscle cells working properly. It provides potassium ions that replace those lost from the body, supporting normal electrical activity of the heart. It is classified as a potassium supplement and electrolyte replacement.
Glucose
The 50 % glucose solution is administered by intravenous infusion as a sterile fluid for perfusion. It is a common, approved source of carbohydrate used to raise blood sugar and prevent hypoglycemia during treatments like high‑dose insulin therapy. It supplies simple sugar that the body can quickly use for energy, especially when insulin is given. It is classified as a carbohydrate solution, used as an energy source in medical care.

Investigated diseases

Non‑toxic acute cardiogenic shock - A sudden weakening of the heart’s pumping ability that is not caused by poison or drug overdose. The heart cannot move enough blood to meet the body’s needs, leading to low blood pressure and reduced flow to organs. As the condition continues, the heart may become even less efficient, causing fatigue, shortness of breath, and swelling in the legs. The lack of adequate blood flow can cause the kidneys and other organs to work less well. If the heart’s function does not improve, the symptoms can become more severe over time.