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

Hainan Medical University

Status and phase: Unknown; Phase 4

Conditions: Sepsis

Treatments: Drug: albumin

Study type: Interventional

Funder types: Other

Identifiers

NCT03153306

HannanPH

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

the "bolus" group

Experimental group

Description:

10ml/kg of the natural colloid 5% albumin was given at 1 hrs.

Treatment:

Drug: albumin

the"continuous" group

Experimental group

Description:

10ml/kg of the natural colloid 5% albumin was given over 6 hrs

Treatment:

Drug: albumin