Comparison of Balanced Crystalloids and Normal Saline in Septic Patients

Overview

In this prospective randomized controlled trial, investigators attempt to study the effects of acetated Ringer's solution on the prognosis and renal function of patients with sepsis in intensive care unit compared with normal saline, and provide evidence for current fluid resuscitation strategies for sepsis.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: April 2021

Detailed Description

During the study period,either normal saline or acetated Ringer's solution will be assigned as resuscitation fluid to the septic patients meeting the inclusion criteria.It is anticipated that about 500 patients will be enrolled during the study period.

Interventions

  • Drug: 0.9% saline
    • we use 0.9% saline in ICU patients with sepsis for resuscitation fluid.
  • Drug: lactated Ringer’s solution
    • we use balanced balanced crystalloids in ICU patients with sepsis for resuscitation fluid.

Arms, Groups and Cohorts

  • Experimental: 0.9% saline
    • We use 0.9% saline for resuscitation fluid in ICU septic patients
  • Experimental: Balanced Crystalloids
    • We use acetated Ringer’s solution for resuscitation fluid in ICU septic patients

Clinical Trial Outcome Measures

Primary Measures

  • Development of kidney injury as defined by the KDIGO criteria.
    • Time Frame: 5 days after the admission
    • Investigators will use the level of creatinine(μmol/L) and body weight adjusted urine(ml/h/kg) for severity assessment of kidney injury
  • Need of renal replacement treatment
    • Time Frame: After the admission and before the discharge from ICU,average 15 days
    • Investigators will assess patients’ kidney function everyday

Secondary Measures

  • ICU stay
    • Time Frame: After the admission and before the discharge from ICU,average 15 days
    • the time of patients’ requirement for critical care
  • 28 days mortality
    • Time Frame: 28 days after the admission in ICU
    • the short time mortality

Participating in This Clinical Trial

Inclusion Criteria

  • Patients diagnosed sepsis aged 18~75 and accepted therapy in ICU Exclusion Criteria:

  • Need of Renal replacement treatment – End-stage renal failure – pregnant woman

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • ZhiYong Peng
  • Collaborator
    • Wu Jieping Medical Foundation
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: ZhiYong Peng, Professor – Zhongnan Hospital
  • Overall Official(s)
    • ZhiYong Peng, professor, Study Director, Zhongnan Hospital
  • Overall Contact(s)
    • Li He, investigator, 008617798258617, helisoul@163.com

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