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

NCT ID: NCT03153306

Last Updated: 2017-05-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2018-03-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

the "bolus" group

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

Group Type: EXPERIMENTAL

albumin

Intervention Type: 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)

the"continuous" group

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

Group Type: EXPERIMENTAL

albumin

Intervention Type: 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)

Interventions

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)

Intervention Type: DRUG

Other Intervention Names

human albumin(Austria)

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Southern Medical University, China

OTHER

Sponsor Role: collaborator

Hainan People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

rui li

Attending Doctor, critical care medicine department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hainan Provincial People'S Hospital

Haikou, Hainan, China

Site Status: RECRUITING

Countries

China

Central Contacts

rui li, PhD Candidate

Role: CONTACT

liruixxmc@163.com

18289559251 ext. +86

Facility Contacts

rui li, PhD Candidate

Role: primary

Other Identifiers

HannanPH

Identifier Type: -

Identifier Source: org_study_id