Comparison of Balanced Crystalloids and Normal Saline in Septic Patients

Not Applicable

• Conditions: Sepsis; Acute Kidney Injury; Septic Shock; Sepsis, Severe
• Interventions: Drug: lactated Ringer's solution; Drug: 0.9% saline

• Registration Number: NCT03685214
• Lead Sponsor: ZhiYong Peng

Brief Summary

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.

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.

Study Timeline

• Study First Submitted: 2018-08-15
• Study First Submitted QC: 2018-09-24
• Study First Posted: 2018-09-26
• Status Verified: 2018-10
• Study Start: 2019-03-01
• Last Update Submitted: 2019-03-23
• Last Update Posted: 2019-03-26
• Primary Completion: 2021-04
• Study Completion: 2021-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Balanced Crystalloids	lactated Ringer's solution	We use acetated Ringer's solution for resuscitation fluid in ICU septic patients
0.9% saline	0.9% saline	We use 0.9% saline for resuscitation fluid in ICU septic patients

Primary Outcome Measures

Name	Time	Method
Development of kidney injury as defined by the KDIGO criteria.	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	After the admission and before the discharge from ICU,average 15 days	Investigators will assess patients' kidney function everyday

Secondary Outcome Measures

Name	Time	Method
ICU stay	After the admission and before the discharge from ICU,average 15 days	the time of patients' requirement for critical care
28 days mortality	28 days after the admission in ICU	the short time mortality

Trial Locations

Locations (1)

Zhongnan Hospital; 🇨🇳 Wuhan, Hubei, China