Normal Saline Versus Balance Salt Solution Resuscitation on Kidney Function

Mahidol University

Status: Unknown

Conditions: Shock; Acute Kidney Injury

Treatments: Drug: sterofundin; Drug: normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT02520804

Si566/2014

Details and patient eligibility

About

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

Full 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)

Enrollment: 107 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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107 participants in 2 patient groups

normal saline

Active Comparator group

Description:

normal saline for fluid resuscitation and maintenance for 72 hours

Treatment:

Drug: normal saline

sterofundin

Experimental group

Description:

sterofundin for fluid resuscitation and maintenance for 72 hours

Treatment:

Drug: sterofundin