Importance of the Infusion Rate for the Plasma Expanding Effect of 5% Albumin in the Septic Patient

Study Overview
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Brief Summary
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Correction of hypovolemia is an important therapeutic measure，Even though there is no consensus regarding infusion rates, a plasma volume (PV) expander is often given at a fast rate to treat a suspected hypovolemia without delay which can be associated with aggravation of adverse interstitial accumulation of macromolecules and fluid, especially in inflammatory conditions such as sepsis.the smallest possible volumes for PV resuscitation to maintain normovolemia should be used to reduce the risk of simultaneous interstitial fluid accumulation. The investigators tested the hypothesis that a slow infusion rate of a PV expander results in better plasma expansion than a fast infusion rate to patients with severe sepsis or septic shock.

Conditions
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Sepsis

Intervention / Treatment
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* Drug: albumin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: admitted to the ICU patients with severe sepsis or septic shock (diagnosis according to the 2012 surviving sepsis campaign guidelines) there is low blood pressure (SBP < 90 or mean arterial pressure(MAP) < 65 or the systolic blood pressure is decreased 40 mmHg more than the basic level) or lactic acid or greater for 4 mmol/l the informed consent Exclusion Criteria: less than 18 years of age more than 80 years old pregnant women albumin allergies the dying patients expected lifetime no more than 24 hours) patient with myocardial infarction, heart failure liver failure refused to sign the informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: the bolus group<br>10ml/kg of the natural colloid 5% albumin was given at 1 hrs. | Drug: albumin<br>* Two groups were formed at random for each fluid. In one group, 10ml/kg of 5% albumin was given over 1 hour (the bolus group), and in the other group, the same volume was given over 6 hrs (thecontinuous group)<br>* Other names: human albumin(Austria);|
| Experimental: thecontinuous group<br>10ml/kg of the natural colloid 5% albumin was given over 6 hrs | Drug: albumin<br>* Two groups were formed at random for each fluid. In one group, 10ml/kg of 5% albumin was given over 1 hour (the bolus group), and in the other group, the same volume was given over 6 hrs (thecontinuous group)<br>* Other names: human albumin(Austria);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extravascular lung water (EVLW) before and after fluid resuscitation | Extravascular lung water （EVLW）is measured by Pulse index continous cardiac output (PICCO) before and after fluid resuscitation in each group | 6 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Albumin