Clinical trial NCT02520804: Normal Saline Versus Balance Salt Solution Resuscitation on Kidney Function
Official title: Effect of Normal Saline Versus Balance Salt Solution Resuscitation on Kidney Function; A Randomized Open Label Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Kidney Injury
Shock
Keywords: balanced salt solution
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2015-08-13
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

Eligibility criteria: 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

Primary outcomes:
measure: acute kidney injury
timeFrame: 7 day
Secondary outcomes:
measure: Requirement of Renal replacement therapy (RRT)
timeFrame: up to 7 day
measure: sodium level
timeFrame: day 1-3
measure: potassium level
timeFrame: day 1-3
measure: chloride level
timeFrame: day 1-3
measure: bicarbonate level
timeFrame: day 1-3
measure: 28-day mortality
timeFrame: 28 days after admission
measure: ICU mortality
timeFrame: ICU admission up to 28 day
measure: hospital stay
timeFrame: during hospital admission up to 28 day
measure: ICU hospital stay
timeFrame: during admission up to 28 day
measure: mean arterial pressure
timeFrame: day1-3
measure: dose of norepinephrine
timeFrame: day1-3
measure: dose of adrenaline
timeFrame: day1-3
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Mahidol University
Study officials:
affiliation: Mahidol University
name: Ranistha Ratanarat, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Perner A, Haase N, Guttormsen AB, Tenhunen J, Klemenzson G, Aneman A, Madsen KR, Moller MH, Elkjaer JM, Poulsen LM, Bendtsen A, Winding R, Steensen M, Berezowicz P, Soe-Jensen P, Bestle M, Strand K, Wiis J, White JO, Thornberg KJ, Quist L, Nielsen J, Andersen LH, Holst LB, Thormar K, Kjaeldgaard AL, Fabritius ML, Mondrup F, Pott FC, Moller TP, Winkel P, Wetterslev J; 6S Trial Group; Scandinavian Critical Care Trials Group. Hydroxyethyl starch 130/0.42 versus Ringer's acetate in severe sepsis. N Engl J Med. 2012 Jul 12;367(2):124-34. doi: 10.1056/NEJMoa1204242. Epub 2012 Jun 27.
citation: Ratanarat R, Hantaweepant C, Tangkawattanakul N, Permpikul C. 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:S61-7.
citation: Yunos NM, Bellomo R, Hegarty C, Story D, Ho L, Bailey M. Association between a chloride-liberal vs chloride-restrictive intravenous fluid administration strategy and kidney injury in critically ill adults. JAMA. 2012 Oct 17;308(15):1566-72. doi: 10.1001/jama.2012.13356.
citation: Shaw AD, Bagshaw SM, Goldstein SL, Scherer LA, Duan M, Schermer CR, Kellum JA. Major complications, mortality, and resource utilization after open abdominal surgery: 0.9% saline compared to Plasma-Lyte. Ann Surg. 2012 May;255(5):821-9. doi: 10.1097/SLA.0b013e31825074f5.
citation: Kidney disease: Improving Global outcomes (KDIGO) Acute kidney injury Work Group. KDIGO Clinical Practice Guideline for Acute Kidney injury.Kidney inter., Suppl.2012;2:1-138