Normal Saline Versus Balance Salt Solution Resuscitation on Kidney Function

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02520804
• Other study ID #: Si566/2014
• Status: Recruiting
• Phase: N/A
• First received: July 29, 2015
• Last updated: March 31, 2016
• Start date: November 2014
• Est. completion date: October 2017

Study information

• Verified date: March 2016
• Source: Mahidol University
• Contact: Ranistha Ratanarat, MD
• Phone: 66896685287
• Email: Ranittha[@]hotmail.com
• Is FDA regulated: No
• Health authority: Thailand: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Kidney Injury
• Shock

Intervention

Drug:
• sterofundin
sterofundin for shock patients in the first 72 hours
• normal saline
Normal saline for shock patients in the first 72 hours

Locations

Country	Name	City	State
Thailand	Mahidol University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (13)

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

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

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