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Evaluation of the clinical and metabolic outcomes of pharmacotherapy based total parental nutrition support in adult patients undergoing bone marrow transplantation

Evaluation of the clinical and metabolic outcomes of pharmacotherapy based total parental nutrition support in adult patients undergoing bone marrow transplantation

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201203041030N9
Enrollment
60
Registered
2012-03-15
Start date
2011-05-22
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parental nutrition support in bone marrow transplantation. Other medical procedures as the cause of abnormal reaction of the patient, or of later complication, without mention of misadventure at the time of the procedure

Interventions

Intervention 1: Intervention Group: Total parentral nutrition (dextrose 10%, aminoacid10%, intralipid 10%, vitamins, trace element daily according to 25-35kcal/kg). Intervention 2: Control group: Par
Treatment - Drugs
Intervention Group: Total parentral nutrition (dextrose 10%, aminoacid10%, intralipid 10%, vitamins, trace element daily according to 25-35kcal/kg)
Control group: Partial parentral nutrition (aminoacid 10% daily, intralipid twice weekly, vitamins max 800 kcal/day)

Sponsors

Hematology-Oncology & SCT Research Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Inclusion criteria: 1- Age =18 years; 2- <50% oral intake due to nausea, vomiting, diarrhea, anorexia, Severe mocusitis or Graft versus host disease (GVHD) and cannot use of entral feeding; 3- albumin<3. Exclusion criteria: 1- Documented history of respiratory, hepatic, renal and cardiac dysfunction.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Length of stay (LOS). Timepoint: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks. Method of measurement: Mediacl record.;Incidence of acute GVHD. Timepoint: Three months after intervention. Method of measurement: Physical Examination.;Nutritional status at discharge. Timepoint: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks. Method of measurement: Subjective global assessment (SGA), nutritional risk screening (NRI), anthropometric measurements, nitrogen balance, and laboratory data (such as albumin, prealbumin and total protein).

Secondary

MeasureTime frame
Days on antibiotics. Timepoint: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks. Method of measurement: Medical record.;Days of fever. Timepoint: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks. Method of measurement: Medical record.;Liver function tests (LFTs). Timepoint: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks. Method of measurement: Laboratory Examination.;Rate of electrolyte disturbance. Timepoint: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks. Method of measurement: Laboratory Examination.;Rate of PN-related complications. Timepoint: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks. Method of measurement: Medical record.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMaryam Mousavi

Hematology-Oncology & SCT Research Center

kh.mousavi@gmail.com+98 21 8490 2645

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026