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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03685214
Other study ID # 2018010
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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