Comparison of Balanced Crystalloids and Normal Saline in Septic Patients

Sepsis Clinical Trial

Official title:

Comparison of Balanced Crystalloids and Normal Saline in Septic Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03685214
• Other study ID #: 2018010
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: May 2021

Study information

• Verified date: October 2018
• Source: Zhongnan Hospital
• Contact: Li He, investigator
• Phone: 008617798258617
• Email: helisoul[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: May 2021
• Est. primary completion date: April 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Sepsis
• Sepsis, Severe
• Septic Shock
• Shock, Septic
• Toxemia

Intervention

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

Locations

Country	Name	City	State
China	Zhongnan Hospital	Wuhan	Hubei

Sponsors (2)

Lead Sponsor	Collaborator
ZhiYong Peng	Wu Jieping Medical Foundation

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of kidney injury as defined by the KDIGO criteria.	Investigators will use the level of creatinine(µmol/L) and body weight adjusted urine(ml/h/kg) for severity assessment of kidney injury	5 days after the admission
Primary	Need of renal replacement treatment	Investigators will assess patients' kidney function everyday	After the admission and before the discharge from ICU,average 15 days
Secondary	ICU stay	the time of patients' requirement for critical care	After the admission and before the discharge from ICU,average 15 days
Secondary	28 days mortality	the short time mortality	28 days after the admission in ICU