Effects of goal-directed fluid therapy using LiDCOrapid system in postoperative outcomes and comparison with standard fluid therapy for patients undergoing spine surgery
Evaluation of effects of goal directed fluid therapy on reduction of postoperative outcomes in patients with spine surgery and and comparison with standard fluid therapy.
Design
After providing explanations about the goals of the research and obtaining informed consent 40 patients will be enrolled in this study. Two arm parallel group randomized trial ( 20 patients in each group). In order to blinding, the patients and Researcher and also statistical specialist who performs data analysis would not have any information about subjects in experimental and control groups.
Settings and conduct
Patients will randomly assign in case and control group. Fluid therapy in case group will be based on LidcoRapid hemodynamic monitor. Fluid therapy in the control group will be performed based on standard protocol. In order to blinding, the patients and Researcher and also statistical specialist who performs data analysis would be blinded.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Age greater than 18
Duration of operation more than 2 hours
Ischemic heart disease
Chronic obstructive pulmonary lung disease
Hypertension
Diabetes mellitus
Exclusion Criteria:
Patient refusal
Irregular heart rhythm
Intervention groups
Case:
Fluid therapy during surgery in this group was base on hemodynamic monitors such as stroke volume variation, cardiac output, Systemic vascular resistance and etc.
Control:
Fluid therapy during surgery in this group was based on standard protocol
Main outcome variables
Base excess
Volume transfused
Urine output (cc)
Hospitalization (day)
Intensive Care Unit admission (day)
Starting solids (hour)
Myocardial infarction
Stroke
Pulmonary thromboembolism
Deep vein thrombosis
Pneumonia
Pulmonary edema
Urinary tract infection
Sepsis
Acute respiratory distress syndrome
Acute renal failure
Postsurgical nausea and vomiting
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190719044274N1
Registration date:2019-09-28, 1398/07/06
Registration timing:prospective
Last update:2019-09-28, 1398/07/06
Update count:0
Registration date
2019-09-28, 1398/07/06
Registrant information
Name
Shervin Shahinpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8800 7624
Email address
sshahinpour@student.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-11, 1398/07/19
Expected recruitment end date
2019-11-15, 1398/08/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of goal-directed fluid therapy using LiDCOrapid system in postoperative outcomes and comparison with standard fluid therapy for patients undergoing spine surgery
Simple randomization
After providing explanations about the goals of the research and obtaining informed consent, 40 patients undergoing Spine surgery will be selected with a simple random sampling method. Then they are divided into the case and control groups by simple randomization method.
Blinding (investigator's opinion)
Double blinded
Blinding description
people who were responsible for making assessments on postoperative outcomes or gathering data on outcome variables were blinded
Also the people who analysed the data collected during this trial were blinded
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of the Tehran University of medical sciences
Street address
Keshavarz Blvd, Qods St, Tehran Town
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2019-05-30, 1398/03/09
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1398.115
Health conditions studied
1
Description of health condition studied
Patients with spine surgery due to Spinal canal stenosis, spondylopathies and etc with past medical history of Hypertension or Diabetes mellitus, Ischemic heart disease, Chronic obstructive pulmonary disease
ICD-10 code
M47
ICD-10 code description
Spondylosis
Primary outcomes
1
Description
Base excess
Timepoint
Before intervention and 1, 2, 3 hours after intervention
Method of measurement
Arterial blood gas
2
Description
Days of hospital stay
Timepoint
ِDays of hospital stay after surgery
Method of measurement
Reading the files and visiting patients
3
Description
Days of Intensive Care Unit stay
Timepoint
Days of Intensive Care Unit stay after surgery
Method of measurement
Reading the files and visiting patients
4
Description
postoperative nausea and vomiting
Timepoint
Nausea and vomiting after 12, 24 and 36 hours after surgery
Method of measurement
History Taking
5
Description
Pulmonary edema
Timepoint
Until 24 hours after surgery
Method of measurement
Chest Radiography and Physical examination
6
Description
Serum Transfusion
Timepoint
During Surgery
Method of measurement
Measurement of Serum given during surgey
7
Description
Oral intake Tolerance
Timepoint
24 hours after surgery
Method of measurement
History taking
Secondary outcomes
1
Description
Acute Respiratory Distress Syndrome
Timepoint
48 hours after surgery
Method of measurement
Chest Radiography, Blood gas analysis
2
Description
Pneumonia
Timepoint
48 hours after surgery
Method of measurement
Clinical manifestation and Chest radiography
3
Description
Myocardial infarction
Timepoint
48 hours after surgery
Method of measurement
Lab tests and Electrocardiography
4
Description
Hospital readmission
Timepoint
30 days after discharge
Method of measurement
Postoperative evaluation
5
Description
Urinary Tract Infection
Timepoint
48 hours after surgery
Method of measurement
Clinical manifestation, Urine analysis
Intervention groups
1
Description
Intervention group: Fluid therapy based on Hemodynamic Monitoring such as Stroke Volume Variation, Cardiac Output, Systemic Vascular Resistance and etc given by LidcoRapid Hemodynamic monitoring. Serum type will be crystalloid (lactated ringer)
Category
Treatment - Other
2
Description
Control group: In Control group fluid therapy would be based on standard protocols which is 4 cc/kg/h. If bleeding reaches to the maximum allowable blood loss blood transfusion will be started. Serum type will be crystalloid (lactated ringer).
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina hospital
Full name of responsible person
Doctor Reza Shariat Moharari
Street address
Sina hospital, Hasan Abad Sqr, Tehran Iran
City
Tehran
Province
Tehran
Postal code
١١٣٦٧٤٦٩١١
Phone
+98 21 6634 8500
Email
Moharari@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Research Assistance of Tehran University of Medical Science
Street address
Central department of Tehran University of Medical Sciences, Qods st, Keshavarz Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
141556446
Phone
+98 21 8163 3685
Email
Moharari@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Reza shariat Moharari
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Tehran University of Medical Sciences, Qods St, Keshavarz blvd, Tehran
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8889 6696
Email
Moharari@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr reza shariat Moharari
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Tehran University of Medical Scinces, Keshavarz Blvd, Qods st, Tehran
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8889 6696
Email
Moharari@tums.c.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shervin Shahinpour
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Hasan abad sq, Tehran , Sina Hospital
City
Tehran
Province
Tehran
Postal code
١١٣٦٧٤٦٩١١
Phone
+98 21 6634 8500
Email
sshahinpour@student.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
After completion of the study, if necessary, the encoded data will be published along with the article.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Abstract and references
When the data will become available and for how long
6 months after publishing the results
To whom data/document is available
Academic Researchers and Academic Institutes
Under which criteria data/document could be used
When referring to this research, mention the name of the researchers.
From where data/document is obtainable
Mailing address
What processes are involved for a request to access data/document