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Trial record 2 of 5 for:    The Plasma-Lyte 148 Versus Saline (PLUS) study

Plasmalyte Versus Saline in Trauma Patients (ASTRAU)

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ClinicalTrials.gov Identifier: NCT03630224
Recruitment Status : Not yet recruiting
First Posted : August 14, 2018
Last Update Posted : August 14, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:

Fluid resuscitation remains the cornerstone for the care of severe trauma patients to compensate for blood loss, to compensate for capillary leak induced by systemic inflammation but also to prevent the detrimental consequences of traumatic rhabdomyolysis. Isotonic saline (NaCl 0.9%), called "physiological serum" is the standard fluid for the resuscitation of severely injured patients. However, the formulation of NaCl 0.9% is not really physiological since its chloride concentration is 1.5 higher than the one of human plasma. This excessive chloride concentration leads to hyperchloremic acidosis and to a drop in renal perfusion after isotonic saline infusion. For this reason, we wonder whether fluid resuscitation with Plasmalyte would be beneficial for renal function of trauma patients in comparison with NaCl 0.9%. Our research question is:

In a population of trauma patients at high risk of acute kidney injury, does a fluid resuscitation with Plasmalyte Viaflo lower the incidence of severe acute kidney injury (stage 2 or 3 according to the KDIGO classification) compared with a resuscitation with isotonic saline (NaCl 0.9%)?


Condition or disease Intervention/treatment Phase
Severe Trauma Patients Acute Kidney Injury Drug: Plasmalyte Viaflo Drug: NaCl 0.9% Phase 3

Detailed Description:

Fluid resuscitation remains the cornerstone for the care of severe trauma patients to compensate for blood loss, to compensate for capillary leak induced by systemic inflammation but also to prevent the detrimental consequences of traumatic rhabdomyolysis. Isotonic saline (NaCl 0.9%), called "physiological serum" is the standard fluid for the resuscitation of severely injured patients. However, the formulation of NaCl 0.9% is not really physiological since its chloride concentration is 1.5 higher than plasma. This excessive chloride concentration leads to hyperchloremic acidosis and to a drop in renal perfusion after isotonic saline infusion (1). A retrospective study conducted in the perioperative setting (abdominal surgery) reported a significant decrease in mortality and acute kidney injury in 926 patients receiving balanced crystalloid solution compared to a propensity-matched population of 2778 patients receiving isotonic saline (2). Yunos et al. conducted a prospective sequential period study including 760 patients receiving chloride-rich solution during the first 6-month period and 773 patients receiving chloride-poor solution during the next 6-month period (3). They reported a decrease in severe acute kidney injury (I or F in the RIFLE classification) in the group receiving chloride-poor solution. Large retrospective studies in intensive care confirmed a beneficial effect of the use of chloride-poor solutions on survival compared to chloride-rich solutions (4-6). A recent meta-analysis including 5 small size randomized controlled trials, 1 controlled trial and two retrospective studies, reported also a decrease in acute kidney injury (7). A recent multicenter study randomized 2778 patients to receive either Plasmalyte 148 or NaCl 0.9% during their ICU stay (8). No AKI or mortality differences were reported. However, this study included patients with low ICU severity score (mean APACHE II = 14) and at low risk of severe AKI (severe AKI incidence = 9%). Moreover, they received a median amount of fluid of 2000 mL during their ICU stay. This small fluid volume may not be enough to show any difference between rich-chloride and poor-chloride solutions on AKI in this population with low ICU severity scores.

Trauma patients are particularly at risk of AKI during the acute phase of trauma because of hypovolemia (bleeding), rhabdomyolysis and systemic inflammation (traumatic tissue injuries and emergency surgeries). AKI is reported in 18 to 26 % of trauma patients (9,10). In our database (TraumaBase®, traumabase.eu) that included at the time of the study the 6 trauma centers of the Paris area (France), we reported a 24% incidence of severe AKI (stage I or F of the RIFLE classification) in the subpopulation of patients needing at least one red blood cell unit transfusion in the 6 first hours of care. Moreover, this subpopulation receives an average amount of 6000 mL of fluid during the first 24 hours of care. We postulate that trauma patients at high risk of AKI receiving high volume of fluid can be the best population target to demonstrate a beneficial effect of Plasmalyte vs isotonic saline on severe AKI occurrence in a prospective, blinded, randomized manner.

Thus, we formulate the following hypothesis:

In a population of trauma patients, at high risk of AKI, a fluid resuscitation with Plasmalyte Viaflo during the 5 first days of care will lower decrease the incidence of severe acute kidney injury (stage 2 or 3 according to the KDIGO classification) compared with a resuscitation with isotonic saline (NaCl 0.9%)


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 622 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Renal Effects of Fluid Resuscitation With Plasmalyte Viaflo Versus Saline in Trauma Patients (the ASTRAU Study)
Estimated Study Start Date : November 2, 2018
Estimated Primary Completion Date : October 7, 2021
Estimated Study Completion Date : October 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Plasmalyte Viaflo
Intervention type: drug (Plasmalyte Viaflo) Intervention name: plasmalyte Intervention description: fluid resuscitation using exclusively Plasmalyte up to 20L during the first 5 days
Drug: Plasmalyte Viaflo
Intervention description: fluid resuscitation using exclusively Plasmalyte up to 20L during the first 5 days

Active Comparator: NaCl 0.9%
Intervention type: drug (NaCl 0.9%) Intervention name: NaCl 0.9% Intervention description: fluid resuscitation using exclusively NaCl 0.9% up to 20L during the first 5 days
Drug: NaCl 0.9%
Intervention name: NaCl 0.9% Intervention description: fluid resuscitation using exclusively NaCl 0.9% up to 20L during the first 5 days




Primary Outcome Measures :
  1. Proportion of Acute Kidney Injury (stage 2 or 3 according to KDIGO classification) over the 5 first days after trauma [ Time Frame: over the 5 first days after trauma ]

Secondary Outcome Measures :
  1. Proportion of patients requiring renal replacement therapy (during 28 days) [ Time Frame: during 28 days ]
  2. Amount of transfused blood product units (during the first 5 days) [ Time Frame: during the first 5 days ]
  3. Number of days alive without free of mechanical ventilation (during 28 days) [ Time Frame: during 28 days ]
  4. Days spent alive outside the ICU (during 28 days) [ Time Frame: during 28 days ]
  5. Mortality [ Time Frame: at 28 days ]
  6. Difference between the serum creatinine peak in the 5 first days of ICU stay and the baseline creatinine [ Time Frame: during the 5 first days ]


Information from the National Library of Medicine

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

Inclusion Criteria:

  • Severe trauma defined by at least one Vittel criteria
  • Indication for at least one red blood cell unit transfusion within 6 hours after trauma
  • Delay between trauma and study randomization ≤ 6 hours
  • Patient able to give consent or included in emergency situation
  • Patient affiliated to Health security system

Exclusion Criteria:

  • Age < 18 years
  • Chronic kidney disease needing requiring renal replacement therapy
  • Participation to another interventional trial
  • Fluid resuscitation > 4000 mL before inclusion

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): NCT03630224


Contacts
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Contact: Jacques DURANTEAU, MD, PhD +33(0)145213441 jacques.duranteau@aphp.fr
Contact: Anatole HARROIS, MD harroisanatole@yahoo.fr

Locations
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France
Département d'Anesthésie Réanimation - Kremlin Bicêtre Not yet recruiting
Le Kremlin-Bicêtre, France, 94270
Contact: Jacques DURANTEAU, MD, PhD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Jacques DURANTEAU Assistance Publique - Hôpitaux de Paris

Publications:

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03630224     History of Changes
Other Study ID Numbers: P160919J
2017-004206-17 ( Other Identifier: IDRCB )
First Posted: August 14, 2018    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Severe trauma
Acute kidney injury
Fluid resuscitation
Sodium chloride
Plasmalyte

Additional relevant MeSH terms:
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Wounds and Injuries
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Plasma-lyte 148
Ophthalmic Solutions
Pharmaceutical Solutions