Normal Saline Versus Balance Salt Solution Resuscitation on Kidney Function

Not Applicable

• Conditions: Acute Kidney Injury; Shock
• Interventions: Drug: normal saline; Drug: sterofundin

• Registration Number: NCT02520804
• Lead Sponsor: Mahidol University

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)

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2015-07-29
• Study First Submitted QC: 2015-08-09
• Study First Posted: 2015-08-13
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-31
• Last Update Posted: 2016-04-04
• Primary Completion: 2017-06
• Study Completion: 2017-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 107

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
normal saline	normal saline	normal saline for fluid resuscitation and maintenance for 72 hours
sterofundin	sterofundin	sterofundin for fluid resuscitation and maintenance for 72 hours

Primary Outcome Measures

Name	Time	Method
acute kidney injury	7 day	Number of Participants with acute kidney injury divided by KIDNEY DISEASE \| IMPROVING GLOBAL OUTCOMES (KDIGO) Staging

Secondary Outcome Measures

Name	Time	Method
sodium level	day 1-3	change from baseline
Requirement of Renal replacement therapy (RRT)	up to 7 day
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
ICU mortality	ICU admission up to 28 day	Number of Participants death at ICU within 28 day after admission
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)

Trial Locations

Locations (1)

Mahidol University; 🇹🇭 Bangkok, Thailand