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Comparison of Balanced Crystalloids and Normal Saline in Septic Patients

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ClinicalTrials.gov Identifier: NCT03685214
Recruitment Status : Unknown
Verified October 2018 by ZhiYong Peng, Zhongnan Hospital.
Recruitment status was:  Recruiting
First Posted : September 26, 2018
Last Update Posted : March 26, 2019
Sponsor:
Collaborator:
Wu Jieping Medical Foundation
Information provided by (Responsible Party):
ZhiYong Peng, Zhongnan Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Sepsis Acute Kidney Injury Septic Shock Sepsis, Severe Drug: 0.9% saline Drug: lactated Ringer's solution Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
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
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Comparison of Balanced Crystalloids and Normal Saline in Septic Patients
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Arms and Interventions
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Arm Intervention/treatment
Experimental: 0.9% saline
We use 0.9% saline for resuscitation fluid in ICU septic patients
 Drug: 0.9% saline
we use 0.9% saline in ICU patients with sepsis for resuscitation fluid.
Other Name: normal saline
Experimental: Balanced Crystalloids
We use acetated Ringer's solution for resuscitation fluid in ICU septic patients
 Drug: lactated Ringer's solution
we use balanced balanced crystalloids in ICU patients with sepsis for resuscitation fluid.
Other Name: Ringer's lactate


Outcome Measures
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Primary Outcome Measures :
  1. Development of kidney injury as defined by the KDIGO criteria. [ Time Frame: 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

  2. Need of renal replacement treatment [ Time Frame: After the admission and before the discharge from ICU,average 15 days ]
    Investigators will assess patients' kidney function everyday


Secondary Outcome Measures :
  1. ICU stay [ Time Frame: After the admission and before the discharge from ICU,average 15 days ]
    the time of patients' requirement for critical care

  2. 28 days mortality [ Time Frame: 28 days after the admission in ICU ]
    the short time mortality


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03685214


Contacts
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Contact: Li He, investigator 008617798258617 helisoul@163.com
Contact: Li He 008617798258617 helisoul@163.com

Locations
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China, Hubei
Zhongnan Hospital Recruiting
Wuhan, Hubei, China, 434000
Contact: Ying Feng         
Sponsors and Collaborators
ZhiYong Peng
Wu Jieping Medical Foundation
Investigators
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Study Director: ZhiYong Peng, professor Zhongnan Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: ZhiYong Peng, Professor, Zhongnan Hospital
ClinicalTrials.gov Identifier: NCT03685214    
Other Study ID Numbers: 2018010
First Posted: September 26, 2018    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by ZhiYong Peng, Zhongnan Hospital:
sepsis
intensive care unit
acetated Ringer's solution
AKI
 normal saline
prognosis
continuous renal replacement therapy
Additional relevant MeSH terms:
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Sepsis
Toxemia
Acute Kidney Injury
Infections
Systemic Inflammatory Response Syndrome
 Inflammation
Pathologic Processes
Renal Insufficiency
Kidney Diseases
Urologic Diseases