The purpose of this study is to determine Acute kidney injury incidence between sterofundin and normal saline ; Resuscitation shock patients
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
107
sterofundin for shock patients in the first 72 hours
Normal saline for shock patients in the first 72 hours
Mahidol University
Bangkok, Bangkok, Thailand
RECRUITINGacute kidney injury
Number of Participants with acute kidney injury divided by KIDNEY DISEASE \| IMPROVING GLOBAL OUTCOMES (KDIGO) Staging
Time frame: 7 day
Requirement of Renal replacement therapy (RRT)
Time frame: up to 7 day
sodium level
change from baseline
Time frame: day 1-3
potassium level
change from baseline
Time frame: day 1-3
chloride level
change from baseline
Time frame: day 1-3
bicarbonate level
change from baseline
Time frame: day 1-3
28-day mortality
Number of Participants death within 28 day after admission
Time frame: 28 days after admission
ICU mortality
Number of Participants death at ICU within 28 day after admission
Time frame: ICU admission up to 28 day
hospital stay
number of Hospital admission date
Time frame: during hospital admission up to 28 day
ICU hospital stay
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number of Hospital admission date
Time frame: during admission up to 28 day
mean arterial pressure
mmHg (average)
Time frame: day1-3
dose of norepinephrine
(µg/k/min)
Time frame: day1-3
dose of adrenaline
(µg/k/min)
Time frame: day1-3