NCT03685214

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable sepsis

Timeline
Completed

Started Mar 2019

Typical duration for not_applicable sepsis

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 15, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 26, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

March 26, 2019

Status Verified

October 1, 2018

Enrollment Period

2.1 years

First QC Date

August 15, 2018

Last Update Submit

March 23, 2019

Conditions

SepsisAcute Kidney InjurySeptic ShockSepsis, Severe

Keywords

sepsisintensive care unitacetated Ringer's solutionAKInormal salineprognosiscontinuous renal replacement therapy

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (2)

  • ICU stay

    After the admission and before the discharge from ICU,average 15 days

  • 28 days mortality

    28 days after the admission in ICU

Study Arms (2)

0.9% saline

EXPERIMENTAL

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

Drug: 0.9% saline

Balanced Crystalloids

EXPERIMENTAL

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

Drug: lactated Ringer's solution

Interventions

0.9% salineDRUG

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

Also known as: normal saline
0.9% saline
lactated Ringer's solutionDRUG

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

Also known as: Ringer's lactate
Balanced Crystalloids

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed sepsis aged 18\~75 and accepted therapy in ICU

You may not qualify if:

  • Need of Renal replacement treatment
  • End-stage renal failure
  • pregnant woman

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongnan Hospital

Wuhan, Hubei, 434000, China

RECRUITING

Related Publications (2)

  • 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.

    PMID: 38369528DERIVED

  • 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.

    PMID: 33494795DERIVED

MeSH Terms

Conditions

SepsisAcute Kidney InjuryShock, Septic

Interventions

Saline SolutionRinger's Lactate

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesShock

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • ZhiYong Peng, professor

    Zhongnan Hospital

    STUDY DIRECTOR

Central Study Contacts

Li He, investigator

CONTACT

008617798258617helisoul@163.com

Li He

CONTACT

008617798258617helisoul@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: One model using normal saline for resuscitation fluid,the other using acetated Ringer's solution
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 15, 2018

First Posted

September 26, 2018

Study Start

March 1, 2019

Primary Completion

April 1, 2021

Study Completion

May 1, 2021

Last Updated

March 26, 2019

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will share

Locations

CN(1)