Hydration deferred fluid limitation combine with norepinephrine infusion on perioperative and post- operative complications during colorectal surgeries
The aim of this study was to determine the impact of fluid limitation with norepinephrine infusion versus routine fluid therapy on complications during colorectal surgery and post- operative periods. This study based on randomized sampling, double blind and single center study. Inclusion criteria were: patients suffering from colorectal cancer; age group between 20 to 60 years old; nether evidence of Myocardial infarction during last 6 months nor significant cardiovascular disease; neither use of anticoagulants agent nor coagulopathy. Exclusion criteria were: severe hemodynamic instability; oliguria ; anuria and significant Electrocardiographic changes during surgery. Study population included 168 patients with colorectal cancer who were divided randomly in 2 control and intervention groups; For intervention group: induced fluid limitation with norepinephrine infusion during surgery. For control patients administrated routine fluid therapy during surgery. At the end of surgery patients transfer to intensive care unit and follow up for 2 days. Then the hemodynamic changes, Post- operative complications and duration of hospital admission were compared on both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014121120285N1
Registration date:2015-02-22, 1393/12/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-02-22, 1393/12/03
Registrant information
Name
Shervin Malekzadeh
Name of organization / entity
Tehran university of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2828
Email address
shervinmalekzadeh@irimc.org
Recruitment status
Recruitment complete
Funding source
Tehran university of Medical Sciences
Expected recruitment start date
2015-02-20, 1393/12/01
Expected recruitment end date
2015-09-23, 1394/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Hydration deferred fluid limitation combine with norepinephrine infusion on perioperative and post- operative complications during colorectal surgeries
Public title
Impact of fluid limitation combine with norepinephrine infusion during colorectal surgery on perioperative and post-operative complications
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria were: patients suffering from colorectal cancer; age group between 20 to 60 years old; nether evidence of Myocardial infarction during last 6 months nor significant cardiovascular disease; neither use of anticoagulants agent nor coagulopathy. Exclusion criteria were: severe hemodynamic instability; oliguria; anuria and significant Electrocardiographic changes during surgery.
Age
From 20 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
168
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
For the purpose of blinding random allocation was done with other person. Randomization Method: Block randomization was used to equalized the number of patients in both control and intervention groups.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Science
Street address
Ghods St., Keshavarz Blvd Tehran
City
Tehran
Postal code
1417653761
Approval date
2014-06-30, 1393/04/09
Ethics committee reference number
91111074028
Health conditions studied
1
Description of health condition studied
Relation between fluid limitation combine with norepinephrine infusion on perioperative and post- operative complications during colorectal surgeries
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Hypotension during surgery
Timepoint
During procedure till two days after procedure
Method of measurement
Invasive Blood Pressure monitoring by Arterial Catheter
2
Description
Oliguria
Timepoint
During procedure till two days after procedure
Method of measurement
Urine Output Volume
3
Description
Duration of hospital admission after surgery
Timepoint
Time of discharging from hospital
Method of measurement
According to clinical file
Secondary outcomes
empty
Intervention groups
1
Description
After General anesthesia in control group, routine fluid therapy was administrated.
Category
Treatment - Drugs
2
Description
After General anesthesia in intervention group , fluid limitation combine with norepinephrine infusion (4 micro/kg/h) was administrated.
Category
Early detection
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Dr Mojgan Rahimi,
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran university of Medical Science
Full name of responsible person
Dr.Mojgan Rahimi
Street address
Ghods St., Keshavarz Blv Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?