Effects of Parenteral Nutrition in HSCT

NCT ID: NCT04425642

Last Updated: 2021-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-01
• Study Completion Date: 2021-06-01

Brief Summary

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

Detailed 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.

Conditions

Hematologic Malignancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Glucose/Amino acids

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

Group Type: EXPERIMENTAL

Glucose/Amino acids

Intervention Type: DRUG

If indications for parenteral nutrition appear, it's dose will be calculated according patient's age and weight and will consist of glucose and amino acids solutions. To prevent potential complications of parenteral nutrition, the target dose will be reached by the third day of therapy. It will discontinued, when the patient oral food intake will be more than 60% for three consecutive days.

Glucose/Amino acids/Lipids

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

Group Type: EXPERIMENTAL

Glucose/Amino acids/Lipids

Intervention Type: DRUG

If indications for parenteral nutrition appear, it's dose will be calculated according patient's age and weight and will consist of glucose, amino acids and lipid emulsions. To prevent potential complications of parenteral nutrition, the target dose will be reached by the third day of therapy. It will discontinued, when the patient oral food intake will be more than 60% for three consecutive days.

Interventions

Glucose/Amino acids

If indications for parenteral nutrition appear, it's dose will be calculated according patient's age and weight and will consist of glucose and amino acids solutions. To prevent potential complications of parenteral nutrition, the target dose will be reached by the third day of therapy. It will discontinued, when the patient oral food intake will be more than 60% for three consecutive days.

Intervention Type: DRUG

Glucose/Amino acids/Lipids

If indications for parenteral nutrition appear, it's dose will be calculated according patient's age and weight and will consist of glucose, amino acids and lipid emulsions. To prevent potential complications of parenteral nutrition, the target dose will be reached by the third day of therapy. It will discontinued, when the patient oral food intake will be more than 60% for three consecutive days.

Intervention Type: DRUG

Other Intervention Names

Aminoplasmal E 15% 500mL glass bottle; Aminoplasmal E 10% 500mL glass bottle; Aminoven infant 10% 100mL glass bottle; Nutriflex 48/150 1000mL polyethylene 2-chamber bag; Nutriflex 70/240 1500mL polyethylene 2-chamber bag; Glucose 20% 500mL polyethylene bottle; Aminoplasmal E 15% 500mL glass bottle; SMOFlipid 20% 100mL, 250mL, 500mL glass bottle; Nutriflex 70/180 lipid 625mL polyethylene 3-chamber bag; Aminoplasmal E 10% 500mL glass bottle; Aminoven infant 10% 100mL glass bottle; Nutriflex 48/150 1000mL polyethylene 2-chamber bag; Nutriflex 70/240 1500mL polyethylene 2-chamber bag; SMOFKabiven 1477mL polyethylene 3-chamber bag; Glucose 20% 500mL polyethylene bottle

Eligibility Criteria

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

• Minimum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Petersburg State Pavlov Medical University

OTHER

Sponsor Role: lead

Responsible Party

Ivan S Moiseev

Deputy Director for research, Raisa Gorbacheva Memorial Research Institute for Pediatric Oncology, Hematology and Transplantation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alexander Kulagin, Professor

Role: STUDY_DIRECTOR

Pavlov First Saint Petersburg State Medical University

Locations

Pavlov First Saint-Petersburg State Medical University

Saint Petersburg, , Russia

Countries

Russia

Other Identifiers

hsct/pn

Identifier Type: -

Identifier Source: org_study_id