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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

Protocol summary

Summary
The main aim of this study is to evaluate the efficacy of total parental nutrition support in comparison with partial parentral nutrition in adult patients undergoing bone marrow transplantation that due to underlying disease, specific drug effects( conditioning regimens) , and nutritional inadequacy as consequence of gastrointestinal dysfunction such as mucositis, vomiting , anorexia , and diarrhea, as well as possible HSCT complications such as infections and graft versus host disease (GVHD) increase the rate of malnutrition during hospital stay. Sixty adult patients are randomized to receive parentral nutrition (total parental nutrition) (n = 30) or control (partial parentral nutrition) (n = 30)after bone marrow transplant. Demographic data, primary admission diagnosis, concomitant disease(s) and co-administered medication(s) are recorded. Subjective global assessment (SGA), nutritional risk screening (NRI), anthropometric measurements, nitrogen balance, and laboratory data (such as albumin, prealbumin and total protein) serum electrolytes (sodium, potassium, magnesium, phosphate) at baseline (24 h after admission) and weekly thereafter during nutrition therapy , are measured and fallow up 100 days after transplant.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201203041030N9
Registration date: 2012-03-15, 1390/12/25
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-03-15, 1390/12/25
Registrant information
Name
Mahdi Jalili
Name of organization / entity
Hematology-Oncology & SCT Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 8490 2662
Email address
m_jalili@farabi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Hematology Oncology and Stem Cell Transplantation Research Center
Expected recruitment start date
2011-05-22, 1390/03/01
Expected recruitment end date
2012-02-20, 1390/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the clinical and metabolic outcomes of pharmacotherapy based total parental nutrition support in adult patients undergoing bone marrow transplantation
Public title
Evaluation of the clinical and metabolic outcomes of pharmacotherapy based total parental nutrition support in adult patients undergoing bone marrow transplantation
Purpose
Treatment
Inclusion/Exclusion 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.
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Hematology Oncology and Stem Cell Transplantation Research Center
Street address
Shariati Hospital, Kargar Ave
City
Tehran
Postal code
Approval date
2012-03-01, 1390/12/11
Ethics committee reference number
1390/12/11

Health conditions studied

1

Description of health condition studied
Parental nutrition support in bone marrow transplantation
ICD-10 code
Y84
ICD-10 code description
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

Primary outcomes

1

Description
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

2

Description
Incidence of acute GVHD
Timepoint
Three months after intervention
Method of measurement
Physical Examination

3

Description
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 outcomes

1

Description
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

2

Description
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

3

Description
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

4

Description
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

5

Description
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

Intervention groups

1

Description
Intervention Group: Total parentral nutrition (dextrose 10%, aminoacid10%, intralipid 10%, vitamins, trace element daily according to 25-35kcal/kg)
Category
Treatment - Drugs

2

Description
Control group: Partial parentral nutrition (aminoacid 10% daily, intralipid twice weekly, vitamins max 800 kcal/day)
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Hematology-Oncology & SCT Research Center
Full name of responsible person
Street address
Shariati Hospital, Kargar Ave
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hematology-Oncology & SCT Research Center
Full name of responsible person
Molouk Hadjibabaie
Street address
Shariati Hospital, Kargar Ave
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hematology-Oncology & SCT Research Center
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Hematology-Oncology & SCT Research Center
Full name of responsible person
Maryam Mousavi
Position
Pharma Dr.
Other areas of specialty/work
Street address
Shariati Hospital, Kargar Ave
City
Tehran
Postal code
Phone
+98 21 8490 2645
Fax
Email
kh.mousavi@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hematology-Oncology & SCT Research Center
Full name of responsible person
Molouk Hadjibabaie
Position
Associate Professor/Pharma D.
Other areas of specialty/work
Street address
Shariati Hospital, Kargar Ave.
City
Tehran
Postal code
Phone
+98 21 8490 2645
Fax
Email
hajibaba@ tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Hematology-Oncology & SCT Research Center
Full name of responsible person
Mahdi Jalili
Position
M.D.
Other areas of specialty/work
Street address
Shariati Hospital, Kargar Ave.
City
Tehran
Postal code
Phone
+98 21 8490 2645
Fax
Email
horcbmt@sina.tums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
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Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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