Comparison of Balanced Crystalloids and Normal Saline in Septic Patients

Study Overview
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Brief Summary
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In this prospective randomized controlled trial, investigators attempt to study the effects of acetated Ringer's solution on the prognosis and renal function of patients with sepsis in intensive care unit compared with normal saline, and provide evidence for current fluid resuscitation strategies for sepsis.

Detailed Description
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During the study period，either normal saline or acetated Ringer's solution will be assigned as resuscitation fluid to the septic patients meeting the inclusion criteria.It is anticipated that about 500 patients will be enrolled during the study period.

Official Title
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Comparison of Balanced Crystalloids and Normal Saline in Septic Patients

Conditions
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Sepsis, Acute Kidney Injury, Septic Shock, Sepsis, Severe

Intervention / Treatment
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* Drug: 0.9% saline
* Drug: lactated Ringer's solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients diagnosed sepsis aged 18 75 and accepted therapy in ICU Exclusion Criteria: Need of Renal replacement treatment End-stage renal failure pregnant woman

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: One model using normal saline for resuscitation fluid,the other using acetated Ringer's solution
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0.9% saline<br>We use 0.9% saline for resuscitation fluid in ICU septic patients | Drug: 0.9% saline<br>* we use 0.9% saline in ICU patients with sepsis for resuscitation fluid.<br>* Other names: normal saline;|
| Experimental: Balanced Crystalloids<br>We use acetated Ringer's solution for resuscitation fluid in ICU septic patients | Drug: lactated Ringer's solution<br>* we use balanced balanced crystalloids in ICU patients with sepsis for resuscitation fluid.<br>* Other names: Ringer's lactate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of kidney injury as defined by the KDIGO criteria. | Investigators will use the level of creatinine(μmol/L) and body weight adjusted urine(ml/h/kg) for severity assessment of kidney injury | 5 days after the admission | 
| Need of renal replacement treatment | Investigators will assess patients' kidney function everyday | After the admission and before the discharge from ICU,average 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU stay | the time of patients' requirement for critical care | After the admission and before the discharge from ICU,average 15 days | 
| 28 days mortality | the short time mortality | 28 days after the admission in ICU | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sepsis, intensive care unit, acetated Ringer's solution, AKI, normal saline, prognosis, continuous renal replacement therapy