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

Phase 4

• Conditions: Sepsis
• Interventions: Drug: albumin

• Registration Number: NCT03153306
• Lead Sponsor: Hainan People's Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-17
• Study Start: 2016-06
• Status Verified: 2017-05
• Study First Submitted QC: 2017-05-12
• Last Update Submitted: 2017-05-12
• Study First Posted: 2017-05-15
• Last Update Posted: 2017-05-15
• Primary Completion: 2017-12
• Study Completion: 2018-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
the "bolus" group	albumin	10ml/kg of the natural colloid 5% albumin was given at 1 hrs.
the"continuous" group	albumin	10ml/kg of the natural colloid 5% albumin was given over 6 hrs

Primary Outcome Measures

Name	Time	Method
Extravascular lung water (EVLW) before and after fluid resuscitation	6 hour	Extravascular lung water （EVLW）is measured by Pulse index continous cardiac output (PICCO) before and after fluid resuscitation in each group

Trial Locations

Locations (1)

Hainan Provincial People'S Hospital; 🇨🇳 Haikou, Hainan, China