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The Effect of Fluid Resuscitation With 0.9% Sodium Chloride Versus Balanced Crystalloid Solution on Renal Function of Sepsis Patients

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ClinicalTrials.gov Identifier: NCT03277677
Recruitment Status : Recruiting
First Posted : September 11, 2017
Last Update Posted : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
Nattachai Srisawat ,M.D., Chulalongkorn University

Brief Summary:

The high chloride content of 0.9%sodium chloride (0.9%NaCl) leads to adverse pathophysiological effects in both animals and healthy human volunteers. Small randomized trials confirm that the hyperchloremic acidosis induced by 0.9%NaCl also occurs in patients. A strong signal is emerging from recent large propensity-matched and cohort studies for the adverse effects that 0.9% NaCl has on the clinical outcome in surgical and critically ill patients when compared with balanced crystalloids. Major complications are the increased incidences of acute kidney injury and the need for renal replacement therapy, and that pathological hyperchloremia may increase postoperative mortality.

Fluid resuscitation with 0.9% NaCl in animals with sepsis resulted in hyperchloremic metabolic acidosis, worsened AKI, and increased mortality when compared with resuscitation with a balanced crystalloid solution.

Furthermore, hyperchloremic acidosis also resulted in increased concentrations of circulating inflammatory mediators in an experimental model of severe sepsis in rats, with a dose-dependent increase in circulating interleukin-6, tumor necrosis factor-a, and interleukin-10 concentrations with increasing acidosis.

Thus, in this study, investigators compared the effects of a balanced crystalloid solution with 0.9% NaCl on the renal function in severe sepsis/septic shock patients. Investigators hypothesized that balanced crystalloid solution resuscitation would decrease AKI incidence and severity and would improve immunomodulatory effect when compared with 0.9% NaCl resuscitation.


Condition or disease Intervention/treatment Phase
Sepsis Septic Shock Acute Kidney Injury Drug: Normal saline Drug: Ringer's Acetate Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 236 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Fluid Resuscitation With 0.9% Sodium Chloride Versus Balanced Crystalloid Solution on Renal Function of Sepsis Patients
Actual Study Start Date : July 1, 2017
Actual Primary Completion Date : July 1, 2018
Estimated Study Completion Date : October 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Tests Sepsis

Arm Intervention/treatment
Active Comparator: normal saline Drug: Normal saline
for resuscitation in sepsis patients

Active Comparator: balanced solution Drug: Ringer's Acetate
for resuscitation in sepsis patients




Primary Outcome Measures :
  1. The incidence of acute kidney injury for any stage and severity [ Time Frame: at day 7 ]

Secondary Outcome Measures :
  1. The neutrophil function (chemotaxis, CD11b ) between two randomized groups at [ Time Frame: 0, 24, and 72 hours after resuscitation. ]
  2. The monocyte function (HLA-DR) between two randomized groupsafter resuscitation. [ Time Frame: at 0, 24, and 72 hours after resuscitation. ]
  3. The inflammatory marker (IL-6, IL-10) between two randomized groups at [ Time Frame: 0, 24, and 72 hours after resuscitation. ]
  4. Urinary neutrophil gelatinase-associated lipocalin (NGAL) after randomization and after resuscitation with trial fluid [ Time Frame: at 0,24 and 72 hours after resuscitation. ]
  5. Urinary liver-type fatty acid binding protein (L-FABP) [ Time Frame: at 0,24 and 72 hours after resuscitation. ]
  6. Sequential [Sepsis-related] Organ Failure Assessment (SOFA) Score. (excluding Glasgow Coma Score) at 72 hours after randomization. [ Time Frame: at 72 hours after randomization. ]
  7. Need of renal replacement therapy within 72 hours after randomization [ Time Frame: within 72 hours after randomization ]
  8. Days alive without renal replacement therapy [ Time Frame: in 28 days after randomization ]
  9. Hospital length of stay for survivors sanctioned [ Time Frame: at 28 days after randomization ]


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years old
  • Who need fluid resuscitation in the Emergency Room (ER).
  • Who have fulfilled the criteria for sepsis/septic shock within the previous 24 hours according to sepsis is defined as life-threatening organ dysfunction caused by a dysregulated host response to infection.

    o Patients with infection and resulted from a host's systemic inflammatory response syndrome (SIRS) to infection are defined as sepsis if meet the criteria 2 or more of

    • Temperature >38°C or <36°C
    • Heart rate >90/min
    • Respiratory rate >20/min or PaCo2 <32 mm Hg (4.3 kPa)
    • White blood cell count >12000/mm3 or <4000/mm3 or >10% immature bands.
  • Patient who have Septic shock is a subset of sepsis in which underlying circulatory and cellular/metabolic abnormalities are profound enough to substantially increase mortality.

    o Patients with septic shock can be identified with a clinical construct of sepsis with persisting hypotension requiring vasopressors to maintain MAP ≥65 mm Hg and having a serum lactate level >2 mmol/L (18 mg/dL) despite adequate volume resuscitation.

  • AND where informed consent is obtainable either from the patient or by proxy (first degree relative, spouse) if patients aren't in fully conscious status (eg.comatose, drowsiness, irritable).

Exclusion criteria

Exclusion Criteria:

  • Patients with chronic kidney disease (CKD) defined by baseline serum creatinine > 2.0 in male and 1.5 in female.
  • Patients with End stage renal disease (ESRD) with or without renal replacement therapy.
  • Patients with active cardiac disease : severe valvular heart, cardiomyopathy, decompensated heart failure NYHA II-IV, severe pulmonary hypertension.
  • HIV/AIDs Patients.
  • Allergy towards 0.9% NaCl or Ringer's Acetate.
  • Any form of renal replacement therapy.
  • Intracranial bleeding within current hospitalization.
  • Therapy with corticosteroid or non steroidal anti-inflammatory substance.
  • Patients who predicted not to survive more than 24 hours.
  • Pregnant and lactating patients.
  • Withdrawal of active therapy.

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): NCT03277677


Contacts
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Contact: Nattachai Srisawat, MD 6622564000 ext 3597 drnattachai@yahoo.com
Contact: Sasithorn Kunupakan, MD 66831999741 nonghui2010@gmail.com

Locations
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Thailand
Chulalongkorn university Recruiting
Bangkok, Thailand, 10330
Contact: Nattachai Srisawat, MD    6622564000 ext 3597    drnattachai@yahoo.com   
Contact: Sasithorn Kunupakan, MD    66831999741    nonghui2010@gmail.com   
Sponsors and Collaborators
Chulalongkorn University

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Responsible Party: Nattachai Srisawat ,M.D., Associated professor, Chulalongkorn University
ClinicalTrials.gov Identifier: NCT03277677     History of Changes
Other Study ID Numbers: 113/60
First Posted: September 11, 2017    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Sepsis
Toxemia
Acute Kidney Injury
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Pharmaceutical Solutions