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Comparison of two methods of routine fluid therapy and targeted fluid therapy based on peripheral perfusion index in patients with sepsis hospitalized in the intensive care unit of Al-Zahra Hospital: a randomized clinical trial

Protocol summary

Study aim
Comparison of two methods of routine fluid therapy and targeted fluid therapy based on peripheral perfusion index in patients with sepsis hospitalized in the intensive care unit
Design
A clinical trial with a control group, parallel groups, double-blind, and randomized design will be conducted on 60 patients. Restricted randomization using block randomization will be employed for the randomization process.
Settings and conduct
Setting: In the Intensive Care Units of Al-Zahra Hospital in Isfahan, Intervention: eligible patients will be randomly assigned to either a control or intervention group for fluid therapy, with one group receiving a routine approach and the other a targeted approach based on the peripheral perfusion index. Daily measurements will include cumulative fluid balance, and serum creatinine, urine output, and serum cystatin C levels will be monitored at admission and for seven days post-sepsis diagnosis.
Participants/Inclusion and exclusion criteria
The study will include patients with sepsis hospitalized in the intensive care unit, excluding those who are pregnant, have inaccessible peripheral perfusion issues, stage 5 chronic kidney disease, or lack patient consent.
Intervention groups
All patients will be treated per standard sepsis guidelines. The control group will receive 30 mL/kg of Lactated Ringer's solution or crystalloid fluid as determined by the physician. In the intervention group, fluid administration will be based on the peripheral perfusion index, using small, frequent boluses of crystalloids (250-500 mL) over 30 minutes to an hour to maintain the perfusion index above 1/4.
Main outcome variables
The primary outcomes will be the prevalence of peripheral hypo perfusion between the study groups, as well as the mortality rate and the incidence of acute kidney injury between the two groups based on cystatin C, occurring over a 28-day period in the hospital.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240804062637N1
Registration date: 2024-08-16, 1403/05/26
Registration timing: prospective

Last update: 2024-08-16, 1403/05/26
Update count: 0
Registration date
2024-08-16, 1403/05/26
Registrant information
Name
sarah mousavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 7072
Email address
s.mousavi@pharm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-22, 1403/06/01
Expected recruitment end date
2024-12-21, 1403/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of two methods of routine fluid therapy and targeted fluid therapy based on peripheral perfusion index in patients with sepsis hospitalized in the intensive care unit of Al-Zahra Hospital: a randomized clinical trial
Public title
Comparison of fluid therapy methods in patients with sepsis: A clinical trial in the intensive care unit of Al-Zahra Hospital
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with sepsis hospitalized in the intensive care unit
Exclusion criteria:
Inaccessible peripheral perfusion
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, blocks of four will be used to assign patients to each of the study groups. A computer software for random number allocation will be used to assign codes, and patients will be allocated to each of the two study groups in a 1:1 ratio. The coding and allocation to groups will be carried out by the principal investigator of the study.
Blinding (investigator's opinion)
Double blinded
Blinding description
Doctors stationed in the ICU will be blinded to the peripheral perfusion variables. The patients will be unaware as well.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Hazar Jirib Street, Isfahan University of Medical Sciences and Health Services, Central Headquarters
City
Isfahan
Province
Isfehan
Postal code
81746 73461
Approval date
2024-07-31, 1403/05/10
Ethics committee reference number
IR.MUI.PHANUT.REC.1403.061

Health conditions studied

1

Description of health condition studied
Sepsis
ICD-10 code
A41
ICD-10 code description
Other sepsis

Primary outcomes

1

Description
Prevalence of peripheral hypoperfusion among the study groups
Timepoint
Every 30 seconds for 5 minutes daily over a span of seven days
Method of measurement
Pulse oximeter

Secondary outcomes

1

Description
Blood lactate level
Timepoint
Between 6 and 24 hours after sepsis diagnosis
Method of measurement
Blood sample

2

Description
Mean arterial pressure
Timepoint
Between 6 and 24 hours after sepsis diagnosis
Method of measurement
Intensive care monitoring device

3

Description
Serum cystatin C level
Timepoint
Between 6 and 24 hours after sepsis diagnosis
Method of measurement
Blood sample

Intervention groups

1

Description
Control group: Control group: All selected patients will be treated for sepsis based on standard guideline recommendations. According to these guidelines, 30 mL/kg of lactated Ringer's solution or crystalloids will be administered at the doctor’s discretion.
Category
Treatment - Drugs

2

Description
Intervention group: Eligible patients will receive fluids in small, repeated boluses (250-500 mL) of crystalloids over half to one hour to maintain a PI above 1.4. Patients will receive other sepsis treatments based on the hospital protocol.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
Sara Mousavi
Street address
Hazar Jirib Street, Isfahan University of Medical Sciences, Al-Zahra Hospital
City
Isfahan
Province
Isfehan
Postal code
81746 73461
Phone
+98 31 3792 7072
Email
s.mousavi@pharm.mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Research Vice Presidency of Isfahan University of Medical Sciences
Street address
Hazar Jirib Street, Isfahan University of Medical Sciences and Health Services
City
Isfahan
Province
Isfehan
Postal code
81746 73461
Phone
+98 31 3792 7072
Email
s.mousavi@pharm.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Isfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Sara Mousavi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Isfahan, Hazar Jirib Street, Isfahan University of Medical Sciences, School of Pharmacy, Clinical Pharmacy Department
City
Isfahan
Province
Isfehan
Postal code
81746 73461
Phone
+98 31 3792 7072
Email
s.mousavi@pharm.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Sara Mousavi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Isfahan, Hazar Jirib Street, Isfahan University of Medical Sciences, School of Pharmacy, Clinical Pharmacy Departmen
City
Isfahan
Province
Isfehan
Postal code
81746 73461
Phone
+98 31 3792 7072
Email
s.mousavi@pharm.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Sara Mousavi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Isfahan, Hazar Jirib Street, Isfahan University of Medical Sciences, School of Pharmacy, Clinical Pharmacy Department
City
Isfahan
Province
Isfehan
Postal code
81746 73461
Phone
+98 31 3792 7072
Email
s.mousavi@pharm.mui.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Published article
When the data will become available and for how long
one year
To whom data/document is available
The general public
Under which criteria data/document could be used
There are no conditions
From where data/document is obtainable
corresponding author
What processes are involved for a request to access data/document
Email to the corresponding author
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