The effects of hypertonic fluid administration in patients with severe sepsis or septic shock

Completed

• Conditions: Severe sepsis or septic shock; Blood - Other blood disorders

• Registration Number: ACTRN12607000259448
• Lead Sponsor: Dr Frank van Haren

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-05-15
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Patients with severe sepsis or septic shock and need for fluid resuscitation (stroke volume variation > 12% or by clinical judgment)

Exclusion Criteria

Pregnancy, hyponatremia (serum sodium level < 130 mmol/l), hypernatremia (serum sodium level > 150 mmol/l), arrhythmias, myocardial infarction < 1 month prior to study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tonometry: Assuming a baseline value of 10 and a standard deviation of 9 mmHg (based on an earlier study), we calculated a sample size of 24 patients to detect an absolute difference between groups in P[g-a]CO2 gap of 12mmHg after the intervention in a two-sided test with an alpha level of 0.05 and power >80%.[Measured at baseline and every 30 minutes for 6 hours]

Secondary Outcome Measures

Name	Time	Method
Semiquantitative analysis of sublingual microcirculation[Measured at baseline and after 1 hour];Haemodynamic parameters (blood pressure, cardiac output).[Measured at baseline and every 30 minutes for 6 hours.];Expression of mRNA (TF, IL6, IL8, IL10, CD11b, TGFb, MCP1, MMP9, ICAM1, L-selectin, HILG) measured by realtime polymerase chain reaction (PCR) techniques.[Measured at baseline and after 4, 8, 12, and 24 hours.];Systolic and diastolic function as measured with echocardiography.[Measured at baseline and after 1 hour.]