Comparison of Balanced Crystalloids and Normal Saline in Septic Patients

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03685214

Enrollment

500

Registered

2018-09-26

Start date

2019-03-01

Completion date

2021-05-31

Last updated

2019-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

sepsis, intensive care unit, acetated Ringer's solution, AKI, normal saline, prognosis, continuous renal replacement therapy

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.

Interventions

DRUG0.9% saline

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

DRUGlactated Ringer's solution

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Intervention model description

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

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

China

Contacts

Primary ContactLi He, investigator

helisoul@163.com008617798258617

Backup ContactLi He