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

NCT03153306 | Unknown Phase 4 DMC

• 1 other identifier: HannanPH
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis

Keywords

Albumin

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

the "bolus" group

EXPERIMENTAL

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

Drug: albumin

the"continuous" group

EXPERIMENTAL

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

Drug: albumin

Interventions

albumin DRUG

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)

Also known as: human albumin(Austria)

the "bolus" group; the"continuous" group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hainan People's Hospital: lead
• Southern Medical University, China: collaborator

Study Sites (1)

Hainan Provincial People'S Hospital

Haikou, Hainan, 570000, China

RECRUITING

MeSH Terms

Conditions

Sepsis

Interventions

Albumins

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Proteins; Amino Acids, Peptides, and Proteins

Central Study Contacts

rui li, PhD Candidate

CONTACT

18289559251; liruixxmc@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Doctor, critical care medicine department

Study Record Dates

• First Submitted: May 17, 2016
• First Posted: May 15, 2017
• Study Start: June 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: March 1, 2018
• Last Updated: May 15, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)