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Normal Saline Versus Balance Salt Solution Resuscitation on Kidney Function

Primary Purpose

Acute Kidney Injury, Shock

Status

Unknown status

Phase

Not Applicable

Locations

Thailand

Study Type

Interventional

Intervention

sterofundin

normal saline

About this trial

This is an interventional treatment trial for Acute Kidney Injury focused on measuring balanced salt solution

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Mahidol UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

normal saline

sterofundin

Arm Description

normal saline for fluid resuscitation and maintenance for 72 hours

sterofundin for fluid resuscitation and maintenance for 72 hours

Outcomes

Primary Outcome Measures

acute kidney injury

Number of Participants with acute kidney injury divided by KIDNEY DISEASE | IMPROVING GLOBAL OUTCOMES (KDIGO) Staging

Secondary Outcome Measures

Requirement of Renal replacement therapy (RRT)

sodium level

change from baseline

potassium level

change from baseline

chloride level

change from baseline

bicarbonate level

change from baseline

28-day mortality

Number of Participants death within 28 day after admission

ICU mortality

Number of Participants death at ICU within 28 day after admission

hospital stay

number of Hospital admission date

ICU hospital stay

number of Hospital admission date

mean arterial pressure

mmHg (average)

dose of norepinephrine

(µg/k/min)

dose of adrenaline

(µg/k/min)

Full Information

NCT ID

NCT02520804

First Posted

July 29, 2015

Last Updated

March 31, 2016

Sponsor

Mahidol University

1. Study Identification

Unique Protocol Identification Number

NCT02520804

Brief Title

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

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Unknown status

Study Start Date

November 2014 (undefined)

Primary Completion Date

June 2017 (Anticipated)

Study Completion Date

October 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mahidol University

4. Oversight

Data Monitoring Committee

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Kidney Injury, Shock

Keywords

balanced salt solution

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

107 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

normal saline

Arm Type

Active Comparator

Arm Description

normal saline for fluid resuscitation and maintenance for 72 hours

Arm Title

sterofundin

Arm Type

Experimental

Arm Description

sterofundin for fluid resuscitation and maintenance for 72 hours

Intervention Type

Drug

Intervention Name(s)

sterofundin

Other Intervention Name(s)

balance salt solution

Intervention Description

sterofundin for shock patients in the first 72 hours

Intervention Type

Drug

Intervention Name(s)

normal saline

Intervention Description

Normal saline for shock patients in the first 72 hours

Primary Outcome Measure Information:

Title

acute kidney injury

Description

Number of Participants with acute kidney injury divided by KIDNEY DISEASE | IMPROVING GLOBAL OUTCOMES (KDIGO) Staging

Time Frame

7 day

Secondary Outcome Measure Information:

Title

Requirement of Renal replacement therapy (RRT)

Time Frame

up to 7 day

Title

sodium level

Description

change from baseline

Time Frame

day 1-3

Title

potassium level

Description

change from baseline

Time Frame

day 1-3

Title

chloride level

Description

change from baseline

Time Frame

day 1-3

Title

bicarbonate level

Description

change from baseline

Time Frame

day 1-3

Title

28-day mortality

Description

Number of Participants death within 28 day after admission

Time Frame

28 days after admission

Title

ICU mortality

Description

Number of Participants death at ICU within 28 day after admission

Time Frame

ICU admission up to 28 day

Title

hospital stay

Description

number of Hospital admission date

Time Frame

during hospital admission up to 28 day

Title

ICU hospital stay

Description

number of Hospital admission date

Time Frame

during admission up to 28 day

Title

mean arterial pressure

Description

mmHg (average)

Time Frame

day1-3

Title

dose of norepinephrine

Description

(µg/k/min)

Time Frame

day1-3

Title

dose of adrenaline

Description

(µg/k/min)

Time Frame

day1-3

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ranistha Ratanarat, MD

Phone

66896685287

Ranittha@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ranistha Ratanarat, MD

Organizational Affiliation

Mahidol University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mahidol University

City

Bangkok

ZIP/Postal Code

10700

Country

Thailand

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ranistha Rattanarat, MD

Phone

0896685287

Ranittha@hotmail.com

12. IPD Sharing Statement

Citations:

PubMed Identifier

8774792

Citation

Barber AE, Shires GT. Cell damage after shock. New Horiz. 1996 May;4(2):161-7.

Results Reference

background

PubMed Identifier

7813251

Citation

Kristensen SR. Mechanisms of cell damage and enzyme release. Dan Med Bull. 1994 Sep;41(4):423-33.

Results Reference

background

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.

Results Reference

background

Citation

Marino PL.Inflammatory shock syndrome. In:Marino PL,eds. Marino's The ICU Book 4th edition.Philadelphia:Wolters Kluwer,2014.

Results Reference

background

PubMed Identifier

24066745

Citation

Myburgh JA, Mythen MG. Resuscitation fluids. N Engl J Med. 2013 Sep 26;369(13):1243-51. doi: 10.1056/NEJMra1208627. No abstract available.

Results Reference

background

PubMed Identifier

24330733

Citation

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.

Results Reference

background

PubMed Identifier

22580944

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(R) 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.

Results Reference

background

PubMed Identifier

21067552

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.

Results Reference

background

PubMed Identifier

22738085

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. Erratum In: N Engl J Med. 2012 Aug 2;367(5):481.

Results Reference

background

PubMed Identifier

19562988

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.

Results Reference

background

PubMed Identifier

23073953

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.

Results Reference

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PubMed Identifier

22470070

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.

Results Reference

background

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

Results Reference

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Normal Saline Versus Balance Salt Solution Resuscitation on Kidney Function

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