Normal Saline Versus Balance Salt Solution Resuscitation on Kidney Function

Study Overview
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Brief Summary
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The purpose of this study is to determine Acute kidney injury incidence between sterofundin and normal saline ; Resuscitation shock patients

Detailed Description
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Sample size:Compare proportion for independent two groups formula. n=sample size α risk of 0.05, Statistical power of 80% P1 =incidence of acute kidney injury (AKI) in control (0.6)* P2 =incidence of acute kidney injury (AKI) in balanced salt solution (0.4)** from Ratanarat R,Hantaweepant C,Tangkawattanakul N,et al.The clinical outcome of acute kidney injury in critically ill Thai patients stratified with RIFLE classification.J Med Assoc Thai 2009 Mar;92 Suppl 2:61-7. α risk of 0.05, Statistical power of 80% Sample size for interim analysis 1.11 x 97 = 107.67 total 108 (at least 50 cases each arm)

Official Title
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Effect of Normal Saline Versus Balance Salt Solution Resuscitation on Kidney Function; A Randomized Open Label Controlled Study

Conditions
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Acute Kidney Injury, Shock

Intervention / Treatment
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* Drug: sterofundin
* Drug: normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Shock patients (hypotension with signs of poor tissue perfusion) Exclusion Criteria: Age < 18 yr Cardiogenic shock patients (History of ST elevation and Left ventricular ejection fraction (LVEF) < 35%), Prolong shock >24 hrs, Received chloride rich crystalloid (0.9% saline) or chloride rich colloid > 1000 ml within 72 hrs before recruitment Do-not-resuscitation patients, Contraindication for IV fluid administration such as pulmonary edema., Stage V chronic kidney disease (CKD), chronic Hemodialysis or Peritonealdialyse

Ages Eligible for Study
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Minimum Age: 18 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: normal saline<br>normal saline for fluid resuscitation and maintenance for 72 hours | Drug: normal saline<br>* Normal saline for shock patients in the first 72 hours<br>|
| Experimental: sterofundin<br>sterofundin for fluid resuscitation and maintenance for 72 hours | Drug: sterofundin<br>* sterofundin for shock patients in the first 72 hours<br>* Other names: balance salt solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| acute kidney injury | Number of Participants with acute kidney injury divided by KIDNEY DISEASE | IMPROVING GLOBAL OUTCOMES (KDIGO) Staging | 7 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Requirement of Renal replacement therapy (RRT) |  | up to 7 day | 
| sodium level | change from baseline | day 1-3 | 
| potassium level | change from baseline | day 1-3 | 
| chloride level | change from baseline | day 1-3 | 
| bicarbonate level | change from baseline | day 1-3 | 
| 28-day mortality | Number of Participants death within 28 day after admission | 28 days after admission | 
| ICU mortality | Number of Participants death at ICU within 28 day after admission | ICU admission up to 28 day | 
| hospital stay | number of Hospital admission date | during hospital admission up to 28 day | 
| ICU hospital stay | number of Hospital admission date | during admission up to 28 day | 
| mean arterial pressure | mmHg (average) | day1-3 | 
| dose of norepinephrine | (µg/k/min) | day1-3 | 
| dose of adrenaline | (µg/k/min) | day1-3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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balanced salt solution