Severe Trauma PatientsPhase 3ASTRAUNCT03630224
Plasmalyte Versus Saline in Trauma Patients
A Phase 3 study testing Plasmalyte Viaflo and NaCl 0.9% in people with Severe Trauma Patients and Acute Kidney Injury, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Trauma Patients, Acute Kidney Injury
- What is being tested?
- Plasmalyte Viaflo and NaCl 0.9%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 365 participants
- Where
- 1 siteFrance
- Study dates
- 24 Jun 2019to 18 Aug 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Severe trauma defined by at least one Vittel criteria
- Prescription 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
Who cannot join
- Age < 18 years
- Chronic kidney disease needing requiring renal replacement therapy
- Participation to another interventional trial interacting with renal function or which requires the use of a fluid resuscitation
- Fluid resuscitation > 4000 mL before inclusion
Trial locations and contacts
1 site in 1 country.
France1 site
Département d'Anesthésie Réanimation - Kremlin Bicêtre
Le Kremlin-Bicêtre, 94270
About this study
Official title: Renal Effects of Fluid Resuscitation With Plasmalyte Viaflo Versus Saline in Trauma Patients (the ASTRAU Study)
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%)?
Read the 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. 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. 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. 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. 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. A recent multicenter study randomized 2778 patients to receive either Plasmalyte 148 or NaCl 0.9% during their ICU stay. 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. 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%)
- Conditions
- Severe Trauma Patients, Acute Kidney Injury
- Being tested
- Plasmalyte Viaflo, NaCl 0.9%
- Keywords
- Severe trauma, Acute kidney injury, Fluid resuscitation, Sodium chloride, Plasmalyte
- Medical subject headings
- Acute Kidney Injury, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasmalyte ViafloDrug
Intervention description: fluid resuscitation using exclusively Plasmalyte up to 20L during the first 5 days
NaCl 0.9%Drug
Intervention name: NaCl 0.9% Intervention description: fluid resuscitation using exclusively NaCl 0.9% up to 20L during the first 5 days
| Study group | Role | What they receive |
|---|---|---|
| Plasmalyte Viaflo | Experimental | Intervention type: drug (Plasmalyte Viaflo) Intervention name: plasmalyte Intervention description: fluid resuscitation using exclusively Plasmalyte up to 20L during the first 5 days Receives: Drug: Plasmalyte Viaflo |
| NaCl 0.9% | Active comparator | 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 Receives: Drug: NaCl 0.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Acute Kidney Injury (stage 2 or 3 according to KDIGO classification) over the 5 first days after trauma
Measured: over the 5 first days after trauma
Secondary outcomes (6)
Proportion of patients requiring renal replacement therapy (during 28 days)
Measured: during 28 days
Amount of transfused blood product units (during the first 5 days)
Measured: during the first 5 days
Number of days alive without free of mechanical ventilation (during 28 days)
Measured: during 28 days
Days spent alive outside the ICU (during 28 days)
Measured: during 28 days
Mortality
Measured: at 28 days
Difference between the serum creatinine peak in the 5 first days of ICU stay and the baseline creatinine
Measured: during the 5 first days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start24 Jun 2019
- Primary completion18 Aug 2023
- Study completion18 Aug 2023
Why it stopped: Premature termination due to futility following interim analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Severe Trauma PatientsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 365 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anatole HARROIS, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03630224
- Sponsor's protocol ID
- P160919J
- Other IDs
- 2017-004206-17, 2017
- Acronym
- ASTRAU
- Status last verified
- Jan 2024
- First submitted
- 10 Aug 2018
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chowdhury AH, Cox EF, Francis ST, Lobo DN. A randomized, controlled, double-blind crossover study on the effects of 2-L infusions of 0.9% saline and plasma-lyte(R) 148 on renal blood flow velocity and renal cortical tissue perfusion in healthy volunteers. Ann Surg. 2012 Jul;256(1):18-24. doi: 10.1097/SLA.0b013e318256be72.
PubMed 22580944Shaw AD, Bagshaw SM, Goldstein SL, Scherer LA, Duan M, Schermer CR, Kellum JA. Major complications, mortality, and resource utilization after open abdominal surgery: 0.9% saline compared to Plasma-Lyte. Ann Surg. 2012 May;255(5):821-9. doi: 10.1097/SLA.0b013e31825074f5.
PubMed 22470070Yunos NM, Bellomo R, Hegarty C, Story D, Ho L, Bailey M. Association between a chloride-liberal vs chloride-restrictive intravenous fluid administration strategy and kidney injury in critically ill adults. JAMA. 2012 Oct 17;308(15):1566-72. doi: 10.1001/jama.2012.13356.
PubMed 23073953Shaw AD, Raghunathan K, Peyerl FW, Munson SH, Paluszkiewicz SM, Schermer CR. Association between intravenous chloride load during resuscitation and in-hospital mortality among patients with SIRS. Intensive Care Med. 2014 Dec;40(12):1897-905. doi: 10.1007/s00134-014-3505-3. Epub 2014 Oct 8.
PubMed 25293535Raghunathan K, Shaw A, Nathanson B, Sturmer T, Brookhart A, Stefan MS, Setoguchi S, Beadles C, Lindenauer PK. Association between the choice of IV crystalloid and in-hospital mortality among critically ill adults with sepsis*. Crit Care Med. 2014 Jul;42(7):1585-91. doi: 10.1097/CCM.0000000000000305.
PubMed 24674927Shaw AD, Schermer CR, Lobo DN, Munson SH, Khangulov V, Hayashida DK, Kellum JA. Impact of intravenous fluid composition on outcomes in patients with systemic inflammatory response syndrome. Crit Care. 2015 Sep 12;19(1):334. doi: 10.1186/s13054-015-1045-z.
PubMed 26370823Krajewski ML, Raghunathan K, Paluszkiewicz SM, Schermer CR, Shaw AD. Meta-analysis of high- versus low-chloride content in perioperative and critical care fluid resuscitation. Br J Surg. 2015 Jan;102(1):24-36. doi: 10.1002/bjs.9651. Epub 2014 Oct 30.
PubMed 25357011Young P, Bailey M, Beasley R, Henderson S, Mackle D, McArthur C, McGuinness S, Mehrtens J, Myburgh J, Psirides A, Reddy S, Bellomo R; SPLIT Investigators; ANZICS CTG. Effect of a Buffered Crystalloid Solution vs Saline on Acute Kidney Injury Among Patients in the Intensive Care Unit: The SPLIT Randomized Clinical Trial. JAMA. 2015 Oct 27;314(16):1701-10. doi: 10.1001/jama.2015.12334.
PubMed 26444692Bagshaw SM, George C, Gibney RT, Bellomo R. A multi-center evaluation of early acute kidney injury in critically ill trauma patients. Ren Fail. 2008;30(6):581-9. doi: 10.1080/08860220802134649.
PubMed 18661407Bihorac A, Delano MJ, Schold JD, Lopez MC, Nathens AB, Maier RV, Layon AJ, Baker HV, Moldawer LL. Incidence, clinical predictors, genomics, and outcome of acute kidney injury among trauma patients. Ann Surg. 2010 Jul;252(1):158-65. doi: 10.1097/SLA.0b013e3181deb6bc.
PubMed 20562612
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Effects of Fluid Resuscitation With Plasmalyte Viaflo Versus Saline in Trauma Patients (the ASTRAU Study)
- ClinicalTrials.gov ID
- NCT03630224
- Acronym / sponsor ID
- ASTRAU / P160919J
- Conditions
- Severe Trauma Patients, Acute Kidney Injury
- Keywords
- Severe trauma, Acute kidney injury, Fluid resuscitation, Sodium chloride, Plasmalyte
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Premature termination due to futility following interim analysis
- Enrolment
- 365 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 24 Jun 2019 (actual)
- Primary completion
- 18 Aug 2023 (actual)
- Study completion
- 18 Aug 2023 (actual)
- First posted
- 14 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%)?
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. 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. 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. 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. 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. A recent multicenter study randomized 2778 patients to receive either Plasmalyte 148 or NaCl 0.9% during their ICU stay. 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. 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%)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plasmalyte Viaflo | Experimental | Drug: Plasmalyte ViafloIntervention type: drug (Plasmalyte Viaflo) Intervention name: plasmalyte Intervention description: fluid resuscitation using exclusively Plasmalyte up to 20L during the first 5 days |
| NaCl 0.9% | Active comparator | Drug: 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Severe trauma defined by at least one Vittel criteria
- Prescription 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
Key exclusion criteria (4 listed)
- Age < 18 years
- Chronic kidney disease needing requiring renal replacement therapy
- Participation to another interventional trial interacting with renal function or which requires the use of a fluid resuscitation
- Fluid resuscitation > 4000 mL before inclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plasmalyte ViafloIntervention description: fluid resuscitation using exclusively Plasmalyte up to 20L during the first 5 days | Drug | Plasmalyte Viaflo |
| 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% |
Primary outcome
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
6 secondary outcomes
Proportion of patients requiring renal replacement therapy (during 28 days)
Time frame: during 28 days
Amount of transfused blood product units (during the first 5 days)
Time frame: during the first 5 days
Number of days alive without free of mechanical ventilation (during 28 days)
Time frame: during 28 days
Days spent alive outside the ICU (during 28 days)
Time frame: during 28 days
Mortality
Time frame: at 28 days
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
Results and safety
The study was stopped early (reason given: Premature termination due to futility following interim analysis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- Background: PubMed 22580944Chowdhury AH, Cox EF, Francis ST, Lobo DN. A randomized, controlled, double-blind crossover study on the effects of 2-L infusions of 0.9% saline and plasma-lyte(R) 148 on renal blood flow velocity and renal cortical tissue perfusion in healthy volunteers. Ann Surg. 2012 Jul;256(1):18-24. doi: 10.1097/SLA.0b013e318256be72.
- Background: PubMed 22470070Shaw AD, Bagshaw SM, Goldstein SL, Scherer LA, Duan M, Schermer CR, Kellum JA. Major complications, mortality, and resource utilization after open abdominal surgery: 0.9% saline compared to Plasma-Lyte. Ann Surg. 2012 May;255(5):821-9. doi: 10.1097/SLA.0b013e31825074f5.
- Background: PubMed 23073953Yunos NM, Bellomo R, Hegarty C, Story D, Ho L, Bailey M. Association between a chloride-liberal vs chloride-restrictive intravenous fluid administration strategy and kidney injury in critically ill adults. JAMA. 2012 Oct 17;308(15):1566-72. doi: 10.1001/jama.2012.13356.
- Background: PubMed 25293535Shaw AD, Raghunathan K, Peyerl FW, Munson SH, Paluszkiewicz SM, Schermer CR. Association between intravenous chloride load during resuscitation and in-hospital mortality among patients with SIRS. Intensive Care Med. 2014 Dec;40(12):1897-905. doi: 10.1007/s00134-014-3505-3. Epub 2014 Oct 8.
- Background: PubMed 24674927Raghunathan K, Shaw A, Nathanson B, Sturmer T, Brookhart A, Stefan MS, Setoguchi S, Beadles C, Lindenauer PK. Association between the choice of IV crystalloid and in-hospital mortality among critically ill adults with sepsis*. Crit Care Med. 2014 Jul;42(7):1585-91. doi: 10.1097/CCM.0000000000000305.
- Background: PubMed 26370823Shaw AD, Schermer CR, Lobo DN, Munson SH, Khangulov V, Hayashida DK, Kellum JA. Impact of intravenous fluid composition on outcomes in patients with systemic inflammatory response syndrome. Crit Care. 2015 Sep 12;19(1):334. doi: 10.1186/s13054-015-1045-z.
- Background: PubMed 25357011Krajewski ML, Raghunathan K, Paluszkiewicz SM, Schermer CR, Shaw AD. Meta-analysis of high- versus low-chloride content in perioperative and critical care fluid resuscitation. Br J Surg. 2015 Jan;102(1):24-36. doi: 10.1002/bjs.9651. Epub 2014 Oct 30.
- Background: PubMed 26444692Young P, Bailey M, Beasley R, Henderson S, Mackle D, McArthur C, McGuinness S, Mehrtens J, Myburgh J, Psirides A, Reddy S, Bellomo R; SPLIT Investigators; ANZICS CTG. Effect of a Buffered Crystalloid Solution vs Saline on Acute Kidney Injury Among Patients in the Intensive Care Unit: The SPLIT Randomized Clinical Trial. JAMA. 2015 Oct 27;314(16):1701-10. doi: 10.1001/jama.2015.12334.
- Background: PubMed 18661407Bagshaw SM, George C, Gibney RT, Bellomo R. A multi-center evaluation of early acute kidney injury in critically ill trauma patients. Ren Fail. 2008;30(6):581-9. doi: 10.1080/08860220802134649.
- Background: PubMed 20562612Bihorac A, Delano MJ, Schold JD, Lopez MC, Nathens AB, Maier RV, Layon AJ, Baker HV, Moldawer LL. Incidence, clinical predictors, genomics, and outcome of acute kidney injury among trauma patients. Ann Surg. 2010 Jul;252(1):158-65. doi: 10.1097/SLA.0b013e3181deb6bc.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anatole HARROIS principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Plasmalyte Viaflo and NaCl 0.9% in people with Severe Trauma Patients and Acute Kidney Injury, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Premature termination due to futility following interim analysis). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03630224, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2024.