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Normal Saline Versus Balance Salt Solution Resuscitation on Kidney Function

Acute Kidney Injury Clinical Trial

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

Clinical Trial Summary

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

Clinical Trial Description

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) ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02520804
Study type Interventional
Source Mahidol University
Contact Ranistha Ratanarat, MD
Phone 66896685287
Email Ranittha@hotmail.com
Status Recruiting
Phase N/A
Start date November 2014
Completion date October 2017
View Details
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