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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03153306

Enrollment

Registered

2017-05-15

Start date

2016-06-30

Completion date

2018-03-31

Last updated

2017-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis

Keywords

Albumin

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.

Interventions

DRUGalbumin

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)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

China

Contacts

Primary Contactrui li, PhD Candidate

liruixxmc@163.com18289559251

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026