Comparison of Balanced Crystalloids and Normal Saline in Septic Patients

NCT ID: NCT03685214

Last Updated: 2019-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2021-05-31

Brief Summary

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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

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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.

Conditions

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Sepsis Acute Kidney Injury Septic Shock Sepsis, Severe

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

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

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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0.9% saline

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

Group Type EXPERIMENTAL

0.9% saline

Intervention Type DRUG

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

Balanced Crystalloids

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

Group Type EXPERIMENTAL

lactated Ringer's solution

Intervention Type DRUG

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

Interventions

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0.9% saline

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

Intervention Type DRUG

lactated Ringer's solution

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

Intervention Type DRUG

Other Intervention Names

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normal saline Ringer's lactate

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wu Jieping Medical Foundation

OTHER

Sponsor Role collaborator

ZhiYong Peng

OTHER

Sponsor Role lead

Responsible Party

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ZhiYong Peng

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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ZhiYong Peng, professor

Role: STUDY_DIRECTOR

Zhongnan Hospital

Locations

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Zhongnan Hospital

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Li He, investigator

Role: CONTACT

008617798258617

Li He

Role: CONTACT

008617798258617

Facility Contacts

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Ying Feng

Role: primary

References

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Zhang J, Liu F, Wu Z, Jiang J, Wang B, Qian Y, Suo J, Li Y, Peng Z. ACETATE RINGER'S SOLUTION VERSUS NORMAL SALINE SOLUTION IN SEPSIS: A RANDOMIZED, CONTROLLED TRIAL. Shock. 2024 Apr 1;61(4):520-526. doi: 10.1097/SHK.0000000000002324. Epub 2024 Feb 1.

Reference Type DERIVED
PMID: 38369528 (View on PubMed)

Liu F, Zhang J, Zhu Y, Su L, Li Y, He L, Yu L, Peng Z. Acetate Ringer's solution versus 0.9% saline for septic patients: study protocol for a multi-center parallel controlled trial. Trials. 2021 Jan 25;22(1):89. doi: 10.1186/s13063-020-05007-5.

Reference Type DERIVED
PMID: 33494795 (View on PubMed)

Other Identifiers

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2018010

Identifier Type: -

Identifier Source: org_study_id

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