1. Home
  2. Approved trials
  3. » فارسی

Effect of goal directed fluid therapy on outcomes of patients admitted to ICU following off-pump CABG

Protocol summary

Summary
70 adult patients admitted to ICU after off-pump CABG are recruited for the study. they will randomly divided to either TED (n=35) or control (n=35) groups based on a computed based randomization system. . the patients will be matched regarding risk of the surgery according to EURO II Score. patients in the TED group will receive intravenous fluid based on hemodynamic parameters including ( flow time corrected) FTc, SVI (sstroke volume index), and CI (cardiac index). Fluid therapy will be according to 4-2-1 rule and using heart rate, blood pressure, CVP, and urine output. VBG is taken during 24 hours for lactate and SCVO2 measurements. the primary outcome is comparison of in hospital mortality between the two groups. The secondary outcome include comparing length of hospital stay, nausea, vomiting, renal failure, blood transfusion requirement, mechanical ventilation time, inotrope and vasopressor administration, base deficient, lactate level, and ScVO2.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015103021098N2
Registration date: 2017-07-05, 1396/04/14
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-07-05, 1396/04/14
Registrant information
Name
Shahram Amini
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3852 5209
Email address
aminish@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad university of medical sciences
Expected recruitment start date
2015-11-06, 1394/08/15
Expected recruitment end date
2016-02-04, 1394/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of goal directed fluid therapy on outcomes of patients admitted to ICU following off-pump CABG
Public title
Effect of goal directed fluid therapy on outcomes of patients admitted to ICU following off-pump CABG
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria All adult patients undergoing off-pump CABG Exclusion criteria EF< 40 %; significant valvular disease; obvious coagulopathy; emergency surgery; renal failure, liver failure; heart failure; oropharyngeal pathology; gastric surgery; age > 70 years; patients with high deranagement and hypotensive patients treated with inotrope and vasopressor
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

1

Registry name
0000000
Secondary trial Id
000000
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences
Street address
Ghoreishi office, Daneshgah avenue
City
Mashhad
Postal code
Approval date
2015-10-28, 1394/08/06
Ethics committee reference number
ir.mums.fm.rec.1394.409

Health conditions studied

1

Description of health condition studied
Ischaemic heart diseases
ICD-10 code
I20-I25
ICD-10 code description
Acute myocardial infarction

Primary outcomes

1

Description
blood lactate, SCVO2
Timepoint
During hospital stay
Method of measurement
LACTATE (meq/l) scvo2 (%)

Secondary outcomes

1

Description
mortality
Timepoint
During hospital stay
Method of measurement
Numbers

Intervention groups

1

Description
intervention (group 1) fluid therapy by using esophageal Doppler
Category
Treatment - Other

2

Description
control (group 2) conventional fluid therapy
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza hospital, OPEN HEART SURGERY ICU
Full name of responsible person
dr. Shahram Amini
Street address
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
shahram amini
Street address
Imam Reza hospital
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Azam Moradi Zarmehri
Position
Fellowship of critical care
Other areas of specialty/work
Street address
Imam Reza hospital
City
Mashhad
Postal code
Phone
+98 51 3802 3752
Fax
Email
moradia931@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Shahram Amini
Position
Fellowship of ICU
Other areas of specialty/work
Street address
Imam Reza hospital
City
Mashhad
Postal code
Phone
+98 51 3802 2314
Fax
Email
aminish@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Shahram Amini
Position
Other areas of specialty/work
Street address
Imam Reza hospital
City
Mashhad
Postal code
Phone
00
Fax
Email
aminis@mums.ac.ir
Web page address

Sharing plan

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