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
The purpose of this study is to determine Acute kidney injury incidence between sterofundin and normal saline ; Resuscitation shock patients
Status | Recruiting |
Enrollment | 107 |
Est. completion date | October 2017 |
Est. primary completion date | June 2017 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Thailand | Mahidol University | Bangkok |
Lead Sponsor | Collaborator |
---|---|
Mahidol University |
Thailand,
Barber AE, Shires GT. Cell damage after shock. New Horiz. 1996 May;4(2):161-7. Review. — View Citation
Chowdhury AH, Cox EF, Francis ST, Lobo DN. A randomized, controlled, double-blind crossover study on the effects of 2-L infusions of 0.9% saline and plasma-lyte® 148 on renal blood flow velocity and renal cortical tissue perfusion in healthy volunteers. Ann Surg. 2012 Jul;256(1):18-24. doi: 10.1097/SLA.0b013e318256be72. Erratum in: Ann Surg. 2013 Dec;258(6):1118. — View Citation
Guidet B, Soni N, Della Rocca G, Kozek S, Vallet B, Annane D, James M. A balanced view of balanced solutions. Crit Care. 2010;14(5):325. doi: 10.1186/cc9230. Epub 2010 Oct 21. Review. — View 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
Kristensen SR. Mechanisms of cell damage and enzyme release. Dan Med Bull. 1994 Sep;41(4):423-33. Review. — View Citation
Kumar A, Parrillo J. Shock: Classification,Pathophysiology, and Approach to Management. In: Dellinger R, Parillo J,eds. Critical Care Medicine: Principles of Diagnosis and Management in the Adult. Philadelphia: Mosby Elsevier,2008.
Marino PL.Inflammatory shock syndrome. In:Marino PL,eds. Marino's The ICU Book 4th edition.Philadelphia:Wolters Kluwer,2014.
Martini WZ, Cortez DS, Dubick MA. Comparisons of normal saline and lactated Ringer's resuscitation on hemodynamics, metabolic responses, and coagulation in pigs after severe hemorrhagic shock. Scand J Trauma Resusc Emerg Med. 2013 Dec 11;21:86. doi: 10.1186/1757-7241-21-86. — View Citation
Myburgh JA, Mythen MG. Resuscitation fluids. N Engl J Med. 2013 Sep 26;369(13):1243-51. doi: 10.1056/NEJMra1208627. Review. — View Citation
Perner A, Haase N, Guttormsen AB, Tenhunen J, Klemenzson G, Åneman A, Madsen KR, Møller MH, Elkjær JM, Poulsen LM, Bendtsen A, Winding R, Steensen M, Berezowicz P, Søe-Jensen P, Bestle M, Strand K, Wiis J, White JO, Thornberg KJ, Quist L, Nielsen J, Andersen LH, Holst LB, Thormar K, Kjældgaard AL, Fabritius ML, Mondrup F, Pott FC, Møller 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. Erratum in: N Engl J Med. 2012 Aug 2;367(5):481. — View 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. — View 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. — View Citation
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* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | acute kidney injury | Number of Participants with acute kidney injury divided by KIDNEY DISEASE | IMPROVING GLOBAL OUTCOMES (KDIGO) Staging | 7 day | Yes |
Secondary | Requirement of Renal replacement therapy (RRT) | up to 7 day | Yes | |
Secondary | sodium level | change from baseline | day 1-3 | Yes |
Secondary | potassium level | change from baseline | day 1-3 | Yes |
Secondary | chloride level | change from baseline | day 1-3 | Yes |
Secondary | bicarbonate level | change from baseline | day 1-3 | Yes |
Secondary | 28-day mortality | Number of Participants death within 28 day after admission | 28 days after admission | Yes |
Secondary | ICU mortality | Number of Participants death at ICU within 28 day after admission | ICU admission up to 28 day | Yes |
Secondary | hospital stay | number of Hospital admission date | during hospital admission up to 28 day | Yes |
Secondary | ICU hospital stay | number of Hospital admission date | during admission up to 28 day | Yes |
Secondary | mean arterial pressure | mmHg (average) | day1-3 | Yes |
Secondary | dose of norepinephrine | (µg/k/min) | day1-3 | Yes |
Secondary | dose of adrenaline | (µg/k/min) | day1-3 | Yes |
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