UMIN-CTR Clinical Trial

Public title

A Study on Estimation of Dry Hemoglobin Concentration in Hemodialysis Patients

Acronym

DH Study

Scientific Title

A Study on Estimation of Dry Hemoglobin Concentration in Hemodialysis Patients

Scientific Title:Acronym

DH Study

Region

Japan

Condition

patients on chronic hemodialysis

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

New target hemoglobin concentration using dry hemoglobin in patients on chronic hemodialysis.

Basic objectives2

Others

Basic objectives -Others

Target hemoglobin concentration by erythropoietin treatment in patients on chronic hemodialysis has been a matter of argument. Recent reports have revealed that too high hemoglobin concentration caused cardiovascular events and high mortality. One of the problem of the target hemoglobin concentration is that the measurements of hemoglobin are performed just before hemodialysis (wet hemoglobin concentration). Hemoglobin concentrations after hemodialysis are not known. Hemoglobin concentration after hemodialysis will be increased by ultrafiltration. Measuring hemoglobin concentration after hemodialysis (dry hemoglobin concentration) would be useful as a new target value. Several factors such as serum albumin concentration should influence dry hemoglobin concentration. The purpose of our study is to make a new formula to calculate dry hemoglobin using wet hemoglobin and ultrafiltration volume and to examine the factors that influence dry hemoglobin value.

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

To examine the relatonship between ultrafiltration volume and the increase in hemoglobin concentration.

Key secondary outcomes

Effects of serum albumin level on the increase in hemoglobin concentration by ultrafiltraton.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

patients on chronic hemodialysis

Key exclusion criteria

patients on temprary hemodialysis

Target sample size

500

Name of lead principal investigator

1st name
Middle name
Last name	Hiroshi Nonoguchi, M.D.

Organization

Hyogo College of Medicine

Division name

Division of Kidney and Dialysis, Department of Internal Medicine

Zip code

Address

1-1 Mukogawa-cho, Nishinomiya, hyogo 663-8501, Japan

TEL

0798-45-6521

Email

Name of contact person

1st name
Middle name
Last name	Hiroshi Nonoguchi, M.D.

Organization

Hyogo College of Medicine

Division name

Division of Kidney and Dialysis, Department of Internal Medicine

Zip code

Address

1-1Mukogawa-cho, Nishinomiya, Hyogo 663-8501, Japan

TEL

0798-45-6521

Homepage URL

Email

nono@hyo-med.ac.jp

Institute

Division of Kidney and Dialysis, Department of Internal Medicine,
Hyogo College of Medicine

Institute

Department

Personal name

Organization

Division of Kidney and Dialysis,Department of Internal Medicine, Hyogo College of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

No.613

Org. issuing International ID_1

Hyogo College of Medicine

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

兵庫医科大学病院　(兵庫県）、熊本大学病院(熊本県）、明和病院(兵庫県）、宮本クリニック(兵庫県）、荒尾市民病院(熊本県）、鶴田病院(熊本県）、大矢野クリニック(熊本県）、玉名第一クリニック(熊本県）

Date of disclosure of the study information

2008

Year

08

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

No longer recruiting

Date of protocol fixation

2008

Year

07

Month

03

Day

Date of IRB

Anticipated trial start date

2008

Year

07

Month

01

Day

Last follow-up date

2009

Year

05

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

The following items will be examined before and after hemodialysis only once in each patient. Hemodialysis or hemodiafiltration will be done for 3-4 hrs. Patients who will receive drip infusion of albumin are excluded. [both pre- and post-hemodialysis measurements]Blood cell count: RBC, hemoglobin, hematocrit, WBC, platelet, Blood chemistry: total protein, albumin, urea nitrogen, creatinine, Na, K, Cl, [only pre-hemodialysis] AST, ALT, total cholesterol, choline esterase. Plasma: ANP, BNP. Physical: body weight, water removal (ultrafiltration), blood pressure. The formula calculating dry hemoglobin concentration using wet hemoglobin and ultrafiltration will be made. The influence of serum albumin on dry hemoglobin will be also investigated.

Registered date

2008

Year

07

Month

11

Day

Last modified on

2012

Year

07

Month

13

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001504