Effects of Parenteral Nutrition in HSCT

St. Petersburg State Pavlov Medical University

Status: Completed

Conditions: Hematologic Malignancy

Treatments: Drug: Glucose/Amino acids; Drug: Glucose/Amino acids/Lipids

Study type: Interventional

Funder types: Other

Identifiers

NCT04425642

hsct/pn

Details and patient eligibility

About

Nutritional therapy implementation in hematopoietic stem cell transplantation (HSCT) have undergone changes recently due to new conditioning regimen and graft versus disease prophylaxis, novel enteral and parenteral nutrition solutions: the value of enteral nutrition is increasing, the indications for parenteral nutrition are becoming more strict. The study aims to identify the role of parenteral nutrition in the context of rapidly changing supportive care approaches in HSCT

Full description

The study is interventional: in children and adolescents (2-17 years), adults with blood malignancy and inherited diseases who underwent autologous or allogeneic HSCT, nutritional status, parenteral nutrition tolerability and effectiveness will be assessed before and one month after HSCT. All patients who require parenteral nutrition will pass randomization via envelope technique - solutions containing glucose/amino acids or glucose/amino acids/lipid emulsions. The results will be compared with a control group which will not receive additional nutritional support. The methods used for measurement of nutritional status are: weight, body mass index, bioimpedance and hand grip strength (for adults only), blood tests, diet amount record.

Enrollment: 120 patients

Sex: All

Ages: 2+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Autologous HSCT
• Allogeneic HSCT
• Patients with indications for parenteral nutrition defined as unable to eat more than 50% of oral food intake due to posttransplant complications which leads to malnutrition and malabsorption
• Signed informed consent
• Age > 2 years

Exclusion criteria

• Secondary HSCT

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Glucose/Amino acids

Experimental group

Description:

Patients who will require nutritional support will receive parenteral nutrition consisting of glucose and amino acids according age and weight

Treatment:

Drug: Glucose/Amino acids

Glucose/Amino acids/Lipids

Experimental group

Description:

Patients who will require nutritional support will receive parenteral nutrition consisting of glucose, amino acids and lipid emulsions according age and weight

Treatment:

Drug: Glucose/Amino acids/Lipids