Acute Kidney Injury, Shock
Conditions
Keywords
balanced salt solution
Brief 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)
Interventions
DRUGsterofundin
sterofundin for shock patients in the first 72 hours
DRUGnormal saline
Normal saline for shock patients in the first 72 hours
Sponsors
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| acute kidney injury | 7 day | Number of Participants with acute kidney injury divided by KIDNEY DISEASE \| IMPROVING GLOBAL OUTCOMES (KDIGO) Staging |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| sodium level | day 1-3 | change from baseline |
| potassium level | day 1-3 | change from baseline |
| chloride level | day 1-3 | change from baseline |
| bicarbonate level | day 1-3 | change from baseline |
| 28-day mortality | 28 days after admission | Number of Participants death within 28 day after admission |
| Requirement of Renal replacement therapy (RRT) | up to 7 day | — |
| hospital stay | during hospital admission up to 28 day | number of Hospital admission date |
| ICU hospital stay | during admission up to 28 day | number of Hospital admission date |
| mean arterial pressure | day1-3 | mmHg (average) |
| dose of norepinephrine | day1-3 | (µg/k/min) |
| dose of adrenaline | day1-3 | (µg/k/min) |
| ICU mortality | ICU admission up to 28 day | Number of Participants death at ICU within 28 day after admission |
Countries
Thailand
Contacts
Primary ContactRanistha Ratanarat, MD
Outcome results
None listed