Tetrastarch is a type of colloid used in intravenous solutions for fluid resuscitation and volume expansion in patients, particularly those undergoing surgery or experiencing hypovolemia (low blood volume). It belongs to a class of solutions known as synthetic colloids and is composed of large, complex sugar molecules derived from maize starch.

Tetrastarch solutions are administered intravenously and work by increasing the volume of circulating blood plasma, thereby improving cardiac output and tissue perfusion. They are often used in clinical settings where rapid volume expansion is necessary, such as in cases of severe dehydration, hemorrhage, or shock.

Plasma expander Voluven (6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection). It is utilised to treat hypovolemia and hypotension (due to volume loss).

Tetrastarch Uses:

• Used in the treatment and prevention of hypovolemia, acts as a blood volume expander

Voluven Dose in Adults

Voluven Dose in the treatment of Plasma volume expansion:

• When using tetrastarch to boost blood volume, the typical dose for IV infusion is up to 50 milliliters per kilogram of body weight per day.
• For example, in a person weighing 70 kilograms, this could mean giving up to 3500 milliliters per day.
• You can repeat this over several days if needed.

Note:

• If someone is severely dehydrated, it's best to start with a different type of solution called crystalloid.
• The amount of tetrastarch given each day and how fast it's given depends on how much blood the person has lost, how their blood flow is doing, and how hydrated they are.
• Doctors adjust it based on each person's needs and how they're responding.
• It's important to note that tetrastarch isn't suitable for everyone.
• It's not recommended for people who are critically ill, including those with serious infections like sepsis, those with kidney problems or who are on dialysis, people with bleeding disorders, or those who have bleeding in their brains.

Voluven Dose in Children

Note:

• If someone is very dehydrated, it's better to start with a different kind of liquid called crystalloid.
• The amount and how fast it's given depends on how much blood they've lost, how their blood flow is doing, and if their blood is too diluted.
• Doctors adjust it based on what each person needs for their specific situation.
• This type of solution shouldn't be used for people who are very sick, especially those having open heart surgery with a machine helping their heart and lungs, or those with kidney problems.
• Medical groups that focus on critical care recommend not using similar solutions for severe infections and shock in babies and kids.

Voluven (Tetrastarch) Dose in Volume expansion:

For infants and children under 2 years old:

• The typical dose of tetrastarch for increasing their blood volume through IV infusion ranges from 7 to 25 milliliters per kilogram per dose.
• The average dose reported is about 16 milliliters per kilogram per dose, with a maximum daily dose of 50 milliliters per kilogram per day.

For children aged 2 to 12 years:

• The usual dose ranges from 25 to 47 milliliters per kilogram per dose, with an average reported dose of 36 milliliters per kilogram per dose and a maximum daily dose of 50 milliliters per kilogram per day.

Adolescents:

• Can receive up to 50 milliliters per kilogram per day, with a maximum of 3,500 milliliters daily for a 70-kilogram patient, and this can be repeated over several days.
• These doses were noted in clinical trials, with some reporting a dose of 10 milliliters per kilogram per dose for intraoperative use.

Pregnancy Risk Factor C

• When a medication or substance is classified with a Pregnancy Risk Factor C, it means there's a potential risk of adverse effects on the fetus based on animal studies.
• This classification indicates that caution should be exercised when considering its use during pregnancy, and the potential benefits should be weighed against the possible risks.

Use of Tetrastarch during breastfeeding

• The manufacturer of tetrastarch advises caution when giving it to nursing mothers because it's unclear whether tetrastarch passes into breast milk.
• Without clear information on this, it's difficult to assess the potential risks to breastfeeding infants.

Voluven Dose in Kidney Disease:

• Tetrastarch should not be used in patients who already have kidney problems.
• It's especially important to avoid it if someone's kidneys aren't producing much urine or none at all, and this is not related to low blood volume, or if they're already on dialysis.
• If there are any signs of kidney injury after starting tetrastarch, it should be stopped immediately.
• This caution is because tetrastarch can potentially worsen existing kidney issues or cause new problems with kidney function.

Voluven Dose in Liver disease:

• The manufacturer's instructions don't include any specific adjustments to the dosage of tetrastarch for patients with liver problems.

Side Effects of Tetrastarch (Voluven):

• Dermatologic:
  • Pruritus
  • Skin rash
• Gastrointestinal:
  • Increased serum amylase
• Hematologic & Oncologic:
  • Anemia
  • Coagulation Time Increased
  • Decreased Clotting Factors
  • Decreased Hematocrit
  • Prolonged Prothrombin Time
  • Wound Hemorrhage

Contraindications to Tetrastarch (Voluven):

• Tetrastarch should not be used in individuals who have a hypersensitivity to hydroxyethyl starch or any component of the formulation.
• It's also contraindicated in critically ill adult patients, including those with severe infections like sepsis, as it may increase the risk of mortality and the need for renal replacement therapy.
• Other contraindications include renal failure with low urine production not related to low blood volume, dialysis, any condition of excessive fluid in the body (such as pulmonary edema or congestive heart failure), severe high levels of sodium or chloride in the blood, bleeding inside the skull, severe liver disease, preexisting blood clotting or bleeding disorders, and severe high levels of potassium for the specific product Volulyte in Canada.
• These contraindications are important to consider to ensure patient safety and avoid potential complications.

Warnings and precautions

Anaphylactoid reactions

• Anaphylactoid reactions, which can include symptoms like mild flu-like symptoms, slow or fast heart rate, difficulty breathing due to narrowed airways, or fluid buildup in the lungs not related to heart problems, have been reported with solutions containing hydroxyethyl starch.
• If signs of hypersensitivity occur, treatment should be stopped right away, and appropriate therapy should be given.
• These reactions are serious and need immediate attention to ensure the person's safety.

Bleeding

• For patients undergoing open-heart surgery with the help of a machine called cardiopulmonary bypass, it's crucial to keep an eye on their blood's ability to clot.
• Solutions containing hydroxyethyl starch (HES) have been linked to increased bleeding in these patients.
• If any signs of blood clotting problems appear, treatment with HES should be stopped right away.
• It's also important to avoid using HES in patients who already have problems with blood clotting or bleeding.
• These precautions help prevent complications and ensure the safety of patients undergoing this type of surgery.

Fluid overload:

• Giving tetrastarch can lead to too much fluid in the body, a condition called fluid overload.
• This risk is especially important to consider in patients who are very young or elderly.
• Caution should be taken in these cases to prevent overexpansion of blood volume.
• It's also crucial to avoid using tetrastarch in individuals with heart failure or any other condition where having too much fluid in the body could cause problems.
• If someone has existing heart issues, the dosage of tetrastarch should be adjusted accordingly.
• Additionally, tetrastarch should not be used in patients with preexisting kidney problems to prevent further complications.
• These precautions help ensure the safe use of tetrastarch and minimize the risk of adverse effects.

Hemodilution

• When large volumes of tetrastarch are administered, it can lead to a dilution of the blood, a condition known as hemodilution.
• This dilution can result in a decrease in the concentration of red blood cells, clotting factors, and other proteins in the blood.
• As a result, blood clotting may be affected, leading to prolonged clotting times, such as prothrombin time (PT) and partial thromboplastin time (PTT).
• Additionally, bleeding time may be temporarily prolonged.
• It's important for healthcare providers to be aware of these potential effects and monitor patients closely, especially those at increased risk of bleeding or clotting disorders, to ensure their safety during treatment with tetrastarch.

Hepatic effects

• Monitoring liver function is important when using tetrastarch.

Hepatic impairment

• Tetrastarch should be used cautiously in patients with hepatic (liver) impairment.
• Regular monitoring of liver function is recommended both before starting treatment and periodically throughout the course of treatment.

Renal impairment

• Tetrastarch should be avoided in patients with preexisting renal impairment, as it can potentially worsen kidney function.
• Close monitoring of fluid status, including urine output, is essential in patients receiving tetrastarch.
• If any signs of kidney injury occur, treatment should be stopped immediately.
• Additionally, tetrastarch is contraindicated in patients with low urine production not related to low blood volume (oliguria or anuria) or in patients receiving hemodialysis.
• These precautions are important to minimize the risk of kidney damage and ensure the safety of patients receiving tetrastarch.

Tetrastarch (Hydroxyethyl starch 130/0.4; Voluven): Drug Interaction

Monitoring parameters:

Monitoring during Tetrastarch Treatment

• Blood Pressure: Keep an eye on blood pressure levels.
• Heart Rate: Monitor the heart rate.
• Capillary Refill Time: Check how quickly blood returns to the body's small blood vessels.
• Central Venous Pressure (CVP): Measure the pressure in the large vein returning blood to the heart.
• Right Atrial Pressure (RAP): Monitor the pressure in the right atrium of the heart.
• Mean Arterial Pressure (MAP): Measure the average pressure in the arteries.
• Cardiac Index (if applicable): If a pulmonary artery catheter is in place, keep an eye on cardiac index.
• Pulmonary Capillary Wedge Pressure (PCWP): Measure the pressure in the left side of the heart.
• Systemic Vascular Resistance (SVR): Monitor the resistance to blood flow in the body's blood vessels.
• Pulmonary Vascular Resistance (PVR): Keep an eye on the resistance to blood flow in the lungs' blood vessels.
• Hemoglobin Levels: Check the levels of hemoglobin in the blood.
• Coagulation Parameters: Monitor how well the blood is able to clot.
• Renal Function: Keep an eye on kidney function, especially for at least 90 days after administering tetrastarch.
• Liver Function: Monitor how well the liver is working.
• Urine Output: Keep track of how much urine the body is producing.
• Acid-Base Balance: Check the balance of acids and bases in the body's fluids.

How to administer Tetrastarch (voluven)?

Administering Tetrastarch via IV

• IV Administration Only: Use intravenous (IV) administration exclusively. You can administer it through an infusion pump or via pressure infusion.
• Slow Initial Infusion: Infuse the first 10-20 mL slowly while watching for any signs of an anaphylactoid reaction. Make sure to have epinephrine and resuscitative equipment on hand.
• Pressure Infusion Caution: If using pressure infusion, remove or expel any air from the bag before infusion to prevent air embolism.
• Check for Precipitate: Do not use if there's a crystalline precipitate or if the solution appears turbid deep brown.
• IV Tubing Change: Change the IV tubing at least every 24 hours to prevent any complications.

Mechanism of action of Tetrastarch (Voluven):

• Tetrastarch works by increasing the volume of plasma in the blood.
• It does this because it has a highly colloidal starch structure.
• This means that it's made up of starch particles suspended in a fluid, which helps to expand the volume of the liquid portion of the blood.
• As a result, tetrastarch can effectively increase blood volume, helping to improve circulation and tissue perfusion in the body.

Duration:

• Tetrastarch stays in the body for at least 6 hours.

Distribution:

• It spreads throughout the body, with a volume of distribution (V) of 5.9 liters.

Metabolism:

• Larger molecules of tetrastarch, those over 50,000 daltons, are broken down by plasma α-amylase.

Half-life Elimination:

• It takes about 12 hours for half of the tetrastarch to be eliminated from the body.

Excretion:

• Tetrastarch and its smaller breakdown products are excreted in urine.

Clearance:

• The rate at which tetrastarch is cleared from the body is approximately 31.4 milliliters per minute.

International Brands of Tetrastarch:

• Tetrahes
• TetraHES
• Tetraspan
• Volulyte
• Voluven

Tetrastarch Brands Names in Pakistan:

No Brands Available in Pakistan.