CTRI/2022/10/046875Not yet recruitingPhase 4
Comparative study of Normal saline versus balanced crystalloids as fluid resuscitation in sepsis patients
BMCRI1 site in 1 country365 target enrollmentStarted: October 28, 2022Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 365
- Locations
- 1
- Primary Endpoint
- ICU free days
Study Overview
Brief Summary
This study is intended to compare normal saline versus balanced crystalloids in sepsis patient and to determine possible outcomes and fluid of choice in sepsis patient .
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Sepsis patient admitted to ICU.
Exclusion Criteria
- •Patients with h/o pre existing cardiac dysfunction Patients with intracranial bleed or traumatic brain injury , hemorrhagic shock .
- •Patients with pre existing hyperkalemia Patients with h/o chronic dialysis or renal transplant.
Outcomes
Primary Outcomes
ICU free days
Time Frame: In hospital mortality and ICU mortality at 14 th and 28th day | ICU free days | Number of mechanical ventilator free days
In hospital mortality and ICU mortality
Time Frame: In hospital mortality and ICU mortality at 14 th and 28th day | ICU free days | Number of mechanical ventilator free days
Number of mechanical ventilator free days
Time Frame: In hospital mortality and ICU mortality at 14 th and 28th day | ICU free days | Number of mechanical ventilator free days
Secondary Outcomes
- Receipt of new renal replacement therapy(30 days)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Not Applicable
Use of two different type of fluids in head injury patientsFocal traumatic brain injury, (2) ICD-10 Condition: S069||Unspecified intracranial injury,CTRI/2018/12/016728Institute of Medical Sciences100
Unknown
Not Applicable
Normal Saline Vrs Balanced i.v. Fluids in NeurosurgeryBenign NeoplasmsVascular Malformations, BrainNCT03429127Clinical Hospital Centre Zagreb120
Completed
Not Applicable
Metabolomics of Intraoperative Saline and Balanced Crystalloid InfusionMetabolomicsNCT04137042National Taiwan University Hospital56
Unknown
Not Applicable
Intraoperative Normal Saline Administration and Acute Kidney Injury in Patients Undergoing Liver TransplantationEnd Stage Liver DIseaseLiver CirrhosisLiver Transplant ComplicationsNCT05386953Seoul National University Hospital1,440
Completed
Phase 3
Balanced Solution Versus Saline in Intensive Care StudyCritical IllnessAcute Kidney InjuryNCT02875873Hospital do Coracao11,075