The aim of present study, is to compare the effect of albumin and crystalloid serum as resuscitation fluid in survival of patients with severe sepsis shock. In a single center clinical trial study with control group, 20 patients with severe septic shock whom admitted to surgery intensive care unit (ICU) of Imam Reza Hospital of Tabriz University of Medical Sciences, will include the study. Inclusion criteria are age between 12 to 75 years old, and patients with severe septic shock. Exclusion criteria is contraindication for albumin infusion. Patients with using random numbers table will allocate in two groups of intervention and control group. In control group patients will receive standard treatment for septic shock including crystalloid serum, antibiotics, vasopressor, and heart-lung support, and also proper surgical interventions, and in intervention group in addition to all these treatments 100 CC albumin 20% will add on per liter of crystalloid serum of patients will. This type of fluid resuscitation will continue until death or discharge from the ICU. Patients will follow up for 28 days. The primary outcome of present study is patient survival and organ failure is as secondary variable of present study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016040316473N5
Registration date:2016-07-06, 1395/04/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-07-06, 1395/04/16
Registrant information
Name
Farzad Kakaei
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1334 1317
Email address
fkakaei@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences.
Expected recruitment start date
2016-06-04, 1395/03/15
Expected recruitment end date
2016-07-05, 1395/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of albumin and crystalloid serum as resuscitation fluid in survival of patients with severe sepsis shock
Public title
Comparing the effect of albumin and crystalloid serum as resuscitation fluid in survival of patients with severe sepsis shock
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age between 12 to 75 years old; existence of at least two symptoms of SIRS syndrome (body temperature above 38 or below 36 ° C.; respiratory rate above 20 or PCO2 less than 32 or need for mechanical ventilation; heart rate more than 90, leukocytosis above 12,000 or leukopenia less than 4000 or band cells in peripheral blood smear); existence of a focal infection based on positive culture or existence of an obvious infected area such as peritonitis or pneumonia; need to resuscitation with fluid (tachycardia; systolic blood pressure less than 100 mm Hg or mean arterial pressure less than 75 mm Hg; urine volume less than 0.5 cc/kg/hr; need for vasopressor to maintain blood pressure; central venous pressure (CVP) less than 10 mm Hg).
Exclusion criteria: brain death patients; patients undergoing plasmapheresis; contraindications of albumin infusion; heart failure or pulmonary failure or renal failure; transplant patients; patients with burns; heart surgery at 3 recent months.
Age
From 12 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not 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 Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Daneshgah Street, Tabriz.
City
Tabriz
Postal code
Approval date
2015-10-26, 1394/08/04
Ethics committee reference number
TBZMED.REC.1394.658
Health conditions studied
1
Description of health condition studied
Septic shock
ICD-10 code
R57.2
ICD-10 code description
Septic shock
Primary outcomes
1
Description
Survival of patients
Timepoint
Daily for 28 days
Method of measurement
clinical examination
Secondary outcomes
1
Description
Renal failure
Timepoint
Daily for 28 days
Method of measurement
Creatinine level
Intervention groups
1
Description
In intervention group: fluid resuscitation with crystalloid serum plus 100 cc albumin 20% per 1 liter of crystalloid serum.
Category
Treatment - Drugs
2
Description
In control group: fluid resuscitation only with crystalloid serum.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital of Tabriz University of Medical Sciences
Full name of responsible person
Dr. Farzad Kakaei
Street address
Imam Reza Hospital, Daneshgah street, Tabriz.
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University Of Medical Sciences.
Full name of responsible person
Dr Hasan Soleimanpour
Street address
Deputy of Research and Technology, Central Building of Number Two, Tabriz University of Medical Sciences, Daneshgah Street, Tabriz.
City
Tabriz
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, Tabriz 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
Tabriz University of Medical Sciences.
Full name of responsible person
Dr Farzad Kakaei
Position
Associate Professor of General Surgery
Other areas of specialty/work
Street address
Faculty of Medicine, Tabriz University Of Medical Sciences, Daneshgah Street, Tabriz.
City
Tabriz
Postal code
Phone
+98 41 3334 1317
Fax
Email
Fkakaei@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department Of Surgery, Tabriz University of Medical Sciences.
Full name of responsible person
Dr. Farzad Kakaei
Position
Associate Professor of General Surgery
Other areas of specialty/work
Street address
Department of Surgery, Imam Reza Hospital, Daneshgah Street, Tabriz.
City
Tabriz
Postal code
Phone
+98 41 3334 1317
Fax
Email
Fkakaei@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Ayub Ashegh Vatan
Position
Resident of Surgery Medicine
Other areas of specialty/work
Street address
Faculty of Medicine, Tabriz University Of Medical Sciences, Daneshgah Street, Tabriz.
City
Tabriz
Postal code
Phone
+98 41 3334 1317
Fax
Email
Fkakaei@tbzmed.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)