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

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.

Study Overview

• Status: Unknown
• Conditions: Sepsis
• Intervention / Treatment: Drug: albumin

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Hainan
    • Haikou, Hainan, China, 570000
      • Recruiting
      • Hainan Provincial People's Hospital
      • Contact: rui li, PhD Candidate

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: the "bolus" group; 10ml/kg of the natural colloid 5% albumin was given at 1 hrs.	Drug: albumin; 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 (the"continuous" group); Other Names: human albumin(Austria)
Experimental: the"continuous" group; 10ml/kg of the natural colloid 5% albumin was given over 6 hrs	Drug: albumin; 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 (the"continuous" group); Other Names: human albumin(Austria)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hainan People's Hospital
• Collaborators: Southern Medical University, China

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): March 1, 2018

Study Registration Dates

• First Submitted: May 17, 2016
• First Submitted That Met QC Criteria: May 12, 2017
• First Posted (Actual): May 15, 2017

Study Record Updates

• Last Update Posted (Actual): May 15, 2017
• Last Update Submitted That Met QC Criteria: May 12, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Albumin
• Other Study ID Numbers: HannanPH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes