NCT02520804

Normal Saline Versus Balance Salt Solution Resuscitation on Kidney Function

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 107 (estimated)
• Sponsor: Mahidol University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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)

Conditions

• Acute Kidney Injury
• Shock

Interventions

Type	Name	Description
DRUG	sterofundin	sterofundin for shock patients in the first 72 hours
DRUG	normal saline	Normal saline for shock patients in the first 72 hours

Timeline

• Start date: 2014-11-01
• Primary completion: 2017-06-01
• Completion: 2017-10-01
• First posted: 2015-08-13
• Last updated: 2016-04-04

Locations

1 site across 1 country: Thailand