Effect of intensive dialysis and Hb correction in ESRD patient with high LVEDP and high pulmonary hypertension
Design
The present study is a pre-and post-intervention clinical trial that will be performed on hemodialysis patients with ESRD and high-leve of PH.
interventon is intensive hemodialysis (hemodialysis treatment ≥ 16 hours per week) and hemoglobin correction (erythropoietin injection (rhEPO)).
Settings and conduct
The present study is a pre-and post-intervention clinical trial that will be performed on hemodialysis patients with ESRD and high-level of PH who are referred to Imam Khomeini, Golestan and Razi hospitals in Ahwaz.
A double-blind Doppler echocardiography will be done for all patients before intensive hemodialysis and in follow-up study after dialysis. the result of Chest echocardiography is used to determine pulmonary blood pressure (PAP) and left ventricular function.
In this study, the systolic pulmonary artery pressure greater than 35 mmHg is defined as the criterion for the presence of pulmonary hypertension
Participants/Inclusion and exclusion criteria
Inclusion criteria:
- Age over 18 years
- SPAP> 35 mm Hg
- Serum creatinine 6-2 mg / dL
- consent to participate in the study
Exclusion criteria:
- The presence of parenchymal and vascular diseases such as acute or chronic PET and COPD that individually causes PH
- The presence of acute valve illnesses that individually increase the pH, such as Flail MV Leaflet
- Patients with recent MI
- Patients who have received blood during the study or who have an acute illness that causes hematocrit changes, such as acute bleeding
Intervention groups
intensive hemodialysis and hemoglobin correction
Main outcome variables
PAP; LVEF; systolic; diastolic function LV; GLS
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180212038705N1
Registration date:2018-02-27, 1396/12/08
Registration timing:prospective
Last update:2018-02-27, 1396/12/08
Update count:0
Registration date
2018-02-27, 1396/12/08
Registrant information
Name
Fariba Heidari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3338 2242
Email address
heidari.p@ajums.ac.ir
Recruitment status
Not yet recruiting
Funding source
Expected recruitment start date
2639-05-22, 2018/03/01
Expected recruitment end date
2639-11-19, 2018/08/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effect of intensive dialysis and Hb correction in ESRD patient with high LVEDP and high pulmonary hypertension
Public title
Effect of intensive dialysis and Hb correction in ESRD patient
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
SPAP> 35 mm Hg
Cr 2-6 mg/dL
age >18
Hemodialysis patients with ESRD
Exclusion criteria:
Acute or cاronic PET and COPD
Severe valvular disease
Patients with recent MI
Acute bleeding
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
This study is a clinical trial with before and after intervention (Self-control method)
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapour University of Medical Sciences
Street address
Ahvaz, Golestan, Jundishapour University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
61355393
Approval date
2018-01-23, 1396/11/03
Ethics committee reference number
IR.ajums.REC.1396.911
Health conditions studied
1
Description of health condition studied
End Stage Renal Disease
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
PAP
Timepoint
Before and after hemodialysis
Method of measurement
Chest doppler echocardiography
2
Description
LV function
Timepoint
Before and after hemodialysis
Method of measurement
echocardiography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: ESRD patients after hemodialysis and hemoglobin modification
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Dr. Nehzat Akiash
Street address
Imam Khomeini Hospital, Azadegan Ave
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3222 2818
Email
drdarabi01@gmail.com
2
Recruitment center
Name of recruitment center
Golestan Hospital
Full name of responsible person
Dr. Nehzat Akiash
Street address
Golestan Hospital, Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3374 3001
Email
drdarabi01@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Nehzat Akiash
Street address
Jundishapur University of Medical Sciences, Golestan Highway
City
Ahvaz
Province
South Khorasan
Postal code
61355393
Phone
+98 61 3333 7077
Email
drdarabi01@gmail.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Nehzat Akiash
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
61355393
Phone
+98 61355393
Email
drdarabi01@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Forogh Darabi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
61355393
Phone
+98 916 671 6751
Email
drdarabi01@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Forough Darabi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
61355393
Phone
+98 916 671 6751
Email
drdarabi01@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available