The purpose of this study was to determine the effect of ultrafiltration method Zero-balance the clinical outcome of patients undergoing coronary artery bypass graft (2) Design: This study was a randomized clinical trial with a control group in which the influence of ultrafiltration Z-Buf the clinical outcomes of patients undergoing cardiopulmonary bypass in the intervention and control groups will be investigated.
(3)In the intervention group since the beginning of operation hemofilter connected to a cardiopulmonary bypass system and with constant internal tank volume intravenous normal saline or ringer by adding based on the patient's clinical condition, his blood will be filtered. High potassium in the form of normal saline solution, and if it is normal or low serum lactate ringer will be used. The priming volume of 1/5 liters considered in this study will be told that the remaining volume in the tank after filling pipes at a rate of 300 cc will be. In the event of a drop in hematocrit of 21% of packed red blood cells to increase this amount to over 21% will be used. In the control group routine will be carried out and any other method for ultrafiltration will not be used. (4)Participants, including conditions of entry and main output to study liver failure as ((AST> 40 unit / L) and (ALT> 40 unit / L)
A history of heart surgery
High serum creatinine 1/5 mg / dL, and patients who received the drug because before, during 5 days, have acute kidney failure.
In both carotid narrowing of the carotid artery or one of its
(5)Interventions: the effect of ultrafiltration using Z-Buf the clinical outcome of patients undergoing cardiopulmonary bypass in the intervention and control groups will be investigated
(6) The main outcome variables were studied: clinical implications
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016092229914N1
Registration date:2017-05-01, 1396/02/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-05-01, 1396/02/11
Registrant information
Name
Robabeh Khalili
Name of organization / entity
Iran university Of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 3424 7777
Email address
khalili.r@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
vice chancellor for research Iran university of medical sciences
Expected recruitment start date
2016-11-21, 1395/09/01
Expected recruitment end date
2017-04-21, 1396/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Zero-balance ultrafiltration method to evaluate the effect on clinical outcomes in patients undergoing coronary artery bypass surgery
Public title
Ultrafiltration effect on coronary artery bypass surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Non-inclusion criteria
Liver failure as ((AST> 40 unit / L) and (ALT> 40 unit / L);A history of heart surgery;High serum creatinine1/5mg / dL; And patients who received the drug because before during 5 days acute renal failure have had severe narrowing of the carotid both carotid or one of them; Surgery emergency; IE; Ejection fraction of the left ventricle less than 30 percent of patients with Severe failure right ventricle Hemoglobin less than 10;Mass index BMI greater than 40;Benign and malignant cancers;Clamped aortic bypass for more than 120 minutes and 150 minutes; Pulmonary function test abnormal preoperative FEV1 <65
Exclusion criteria
Prime 8/5000
Autologus do the opposite; Using the CUF; Using MUF; Patient died during surgery; Use of Intraoperative balloon pump;Use of ECMO; The need to stay open sternum after surgery; The patient needs cardiopulmonary resuscitation
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
75
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
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the University of Medical Sciences
Street address
Hemmat Tehran
City
Tehran
Postal code
Approval date
2017-01-07, 1395/10/18
Ethics committee reference number
IR.IUMS.REC 1395.9311584001
Health conditions studied
1
Description of health condition studied
Coronary Artery Disease
ICD-10 code
I25.0
ICD-10 code description
Atherosclerotic cardiovascular disease, so described
Before surgery2.Start operation3.Intraoperative4.End the practice of5.6 hours after surgery
Method of measurement
Arterial blood gas measurement
3
Description
Liver enzymes
Timepoint
Preoperative and postoperative
Method of measurement
Measured by laboratory
4
Description
Kidney enzymes
Timepoint
Preoperative and postoperative
Method of measurement
Measured by laboratory
5
Description
Cardiac arrhythmia
Timepoint
Preoperative and postoperative
Method of measurement
ECG machine
Secondary outcomes
empty
Intervention groups
1
Description
Hemofilter action in the intervention group since the beginning of cardiopulmonary bypass connected to the system and maintain the volume of the tank by adding intravenous normal saline or ringer on the basis of clinical status, His blood will be filtered
Category
Treatment - Other
2
Description
In the control group there is
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Rajai Hospital
Full name of responsible person
Tahereh Najafi
Street address
Rajai Hospital, Valiasr Street, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice CHancellor For Research, Iran university Of Medical Sciences
Full name of responsible person
Seyed Ali Javad Moosavi
Street address
Hemmat, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice CHancellor For Research, Iran university Of Medical Sciences
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
Iran University of Medical Sciences
Full name of responsible person
Robabeh KHalili
Position
Masters Student
Other areas of specialty/work
Street address
School of Nursing, Valiasr street, Tehran
City
Tehran
Postal code
Phone
+98 88882885
Fax
Email
robabekhalili64@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
TaherehNajafi GHezelgeh
Position
Assistant Professor
Other areas of specialty/work
Street address
School of Nursing, Vali Asr Street, Tehran
City
Tehran
Postal code
Phone
+98 88882885
Fax
Email
taherepaniz@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
KHalili
Full name of responsible person
Robabeh
Position
Masters Student
Other areas of specialty/work
Street address
School of Nursing, Valiasr street, Tehran
City
Tehran
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)