Comparison of Balanced Crystalloids and Normal Saline in Septic Patients

Comparison of Balanced Crystalloids and Normal Saline in Septic Patients

Sponsors

Lead sponsor: ZhiYong Peng

Collaborator: Wu Jieping Medical Foundation

Source Zhongnan Hospital
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.

Overall Status Recruiting
Start Date March 1, 2019
Completion Date May 2021
Primary Completion Date April 2021
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Development of kidney injury as defined by the KDIGO criteria. 5 days after the admission
Development of kidney injury as defined by the KDIGO criteria. 5 days after the admission
Development of kidney injury as defined by the KDIGO criteria. 5 days after the admission
Need of renal replacement treatment After the admission and before the discharge from ICU,average 15 days
Need of renal replacement treatment After the admission and before the discharge from ICU,average 15 days
Need of renal replacement treatment After the admission and before the discharge from ICU,average 15 days
Secondary Outcome
Measure Time Frame
ICU stay After the admission and before the discharge from ICU,average 15 days
28 days mortality 28 days after the admission in ICU
Enrollment 500
Condition
Intervention

Intervention type: Drug

Intervention name: 0.9% saline

Description: we use 0.9% saline in ICU patients with sepsis for resuscitation fluid.

Arm group label: 0.9% saline

Other name: normal saline

Intervention type: Drug

Intervention name: lactated Ringer's solution

Description: we use balanced balanced crystalloids in ICU patients with sepsis for resuscitation fluid.

Arm group label: Balanced Crystalloids

Other name: Ringer's lactate

Eligibility

Criteria:

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: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
ZhiYong Peng, professor Study Director Zhongnan Hospital
Overall Contact

Last name: Li He, investigator

Phone: 008617798258617

Email: [email protected]

Location
facility status contact
Zhongnan Hospital Recruiting Ying Feng
Location Countries

China

Verification Date

October 2018

Responsible Party

Responsible party type: Sponsor-Investigator

Investigator affiliation: Zhongnan Hospital

Investigator full name: ZhiYong Peng

Investigator title: Professor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: 0.9% saline

Arm group type: Experimental

Description: We use 0.9% saline for resuscitation fluid in ICU septic patients

Arm group label: Balanced Crystalloids

Arm group type: Experimental

Description: We use acetated Ringer's solution for resuscitation fluid in ICU septic patients

Patient Data Yes
Study Design Info

Allocation: Non-Randomized

Intervention model: Crossover Assignment

Intervention model description: One model using normal saline for resuscitation fluid,the other using acetated Ringer's solution

Primary purpose: Treatment

Masking: Single (Participant)

Source: ClinicalTrials.gov