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Septic ShockPhase 3APROCCHSNCT00625209

Activated Protein C and Corticosteroids for Human Septic Shock

A Phase 3 study testing recombinant human activated protein C and hydrocortisone and fludrocortisone in people with Septic Shock, run by University of Versailles at 4 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aims at comparing the efficacy and safety of recombinant human activated protein C to that of low dose of corticosteroids and at investigating the interaction between these drugs in the management of septic shock Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Septic Shock
What is being tested?
recombinant human activated protein C and hydrocortisone and fludrocortisone
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,241 participants
Where
4 sitesFrance
Study dates
Mar 2008to Jul 2016
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

  • hospitalized in intensive care unit for less than 7 days
  • septic shock for less than 24 hours
  • at least one proven site of infection
  • at least 2 organ dysfunction as defined by a SOFA score =or> to 3 for at least 6 consecutive hours
  • need for vasopressor (dopamine =or>15µg/kg/min or epinephrine/norepinephrine at =or>0,25 µg/kg/min for at least 6 consecutive hours, to maintain systolic arterial pressure at 90 mmHg or more OR mean arterial pressure at 6( mmHg or more
  • informed consent

Who cannot join

  • pregnancy or breath feeding
  • decision not to resuscitate
  • underlying disease with an estimated life expectancy of less than 1 month
  • formal indication for corticosteroids
  • recent surgery (ie within the past 72 hours) or a surgery at high risk of bleeding
  • gastro-intestinal bleeding within the past 6 weeks
Show all 29Show fewer
  • chronic liver disease (Child C)
  • recent trauma (ie within the past 72 hours)
  • intracranial process
  • history of stroke, CNS bleeding or traumatic brain injury within the past 3 months
  • platelet counts of less than 30000 per cubic millimeter
  • formal indication for curative anticoagulant; prophylactic use of heparin is allowed
  • any condition of high risk of bleeding as per patient's primary physicians
  • hypersensitivity of activated drotrecogin alpha or any other component of the drug
  • no affiliation to a social security
  • Amendments to eligibility criteria were:
  • On 27/03/2008: Changes in following exclusion criteria :
  • "surgical procedure in the past 7 days" was changed for "surgical procedure within 72 hours, or any surgery associated with high risk of bleeding, or a planned surgery within 24 h".
  • "chronic liver disease" was clarified as "chronic liver disease with Child score C".
  • "severe thrombopenia" was clarified "as severe thrombopenia (<30,000/mm3, before transfusion).
  • On 25/08/2009: The exclusion criteria: surgical procedure within 72 hours, or any surgery associated with high risk of bleeding, or a planned surgery within 24 h" was changed for "surgical procedure within 12 hours, or any surgery associated with high risk of bleeding
  • On 11/06/2010: the inclusion criteria: admitted to the ICU for < 7 days was removed; and a new exclusion criteria was added: "patients who had a previous episode of sepsis during the same hospital stay
  • On 18/04/2012: following the withdrawal of DAA from the market: the following exclusion criteria (only related to DAA) were removed :
  • any surgery in the past 12 hours, or any surgery associated with high risk of bleeding;
  • chronic liver disease with a Child score C;
  • recent trauma;
  • any intracranial mass, or stroke or head injury in the past 3 months;
  • severe thrombocytopenia (< 30.000 /mm3, before platelet transfusion);
  • formal indication for anticoagulation, or any other condition associated with increased risk of bleeding, as appreciated by the patient's physician.

Trial locations and contacts

4 sites in 1 country.

France4 sites
  • Henri Mondor Hospital

    Créteil, 94

  • Raymond Poincaré Hospital

    Garches, 92380

  • Pitié Salpêtrière Hospital

    Paris, 75

  • Saint Josef Hospital

    Paris, 75

Other trials in France

About this study

Official title: Phase III of Recombinant Human Activated Protein C and Low Dose of Hydrocortisone and Fludrocortisone in Adult Septic Shock

This study aims at comparing the efficacy and safety of recombinant human activated protein C to that of low dose of corticosteroids and at investigating the interaction between these drugs in the management of septic shock

Read the detailed description

Septic shock still places a burden in the healthcare system round around the world. In the early 20ties, clinical trials suggested potential benefits from activated protein C in severe sepsis and of corticosteroids when given to adults with refractory shock. More recent studies suggested that patients with moderate sepsis or septic shock may not benefit from either activated protein C or corticosteroids. Therefore, current international guidelines suggest that physicians may consider using these drugs in the more severe cases of sepsis. The main risk associated with the use of activated protein C is bleeding and the main risk associated with the use of steroids is superinfection. It is paramount that a new adequately powered trial explores the benefit/risk ratio of these two drugs and of their combination in a population of adult patients with septic shock.

After the withdrawal of Xigris in October 2011, the study was suspended and restarted in June 2012 to investigate the benefit to risk ratio of corticosteroids.

Conditions
Septic Shock
Being tested
placebos, hydrocortisone and fludrocortisone and placebo, recombinant human activated protein C and placebos, recombinant human activated protein C and hydrocortisone and fludrocortisone
Keywords
septic shock, coagulation, immunomodulation, survival
Medical subject headings
Shock, Septic, Thrombosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • placebosDrug

    placebo of hydrocortisone as an iv bolus every 6 hours for seven days plus placebo of fludrocortisone given through the nasogastric tube once a day for seven days plus placebo of activated protein C given as a continuous infusion for 96 hours

  • hydrocortisone and fludrocortisone and placeboDrug

    hydrocortisone will be given as 50mg iv bolus every 6 hours for seven days and a tablet of 50µg of fludrocortisone will be given once a day via the nasogastric tube for seven days and a placebo of activated protein C will be given as a continuous infusion for 96 hours

  • recombinant human activated protein C and placebosDrug

    activated protein C will be given as a continuous infusion at a dose of 24 µg/kg/h four 96 hours and hydrocortisone placebo as an iv bolus every 6 hours and fludrocortisone placebo once a day through the gastric tube will be given for seven days

  • recombinant human activated protein C and hydrocortisone and fludrocortisoneDrug

    96 hours continuous infusion of 24µg/kg/h of activated protein C plus seven day treatment with 50mg iv bolus of hydrocortisone every 6 hours and 50µg of fludrocortisone via the nasogastric tube once a day

Study groups in NCT00625209
Study groupRoleWhat they receive
1Placebo comparatorplacebo of hydrocortisone, placebo of fludrocortisone and placebo of activated protein C
Receives: Drug: placebos
2Active comparatorHydrocortisone plus fludrocortisone and a placebo of activated protein C
Receives: Drug: hydrocortisone and fludrocortisone and placebo
3Active comparatorplacebo of hydrocortisone, placebo of fludrocortisone and activated protein C
Receives: Drug: recombinant human activated protein C and placebos
4Active comparatorhydrocortisone plus fludrocortisone plus activated protein C
Receives: Drug: recombinant human activated protein C and hydrocortisone and fludrocortisone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 90-day mortality

    Measured: 90 day

Secondary outcomes (17)
  1. mortality at 28 day

    Measured: 28-day

  2. mortality at ICU discharge

    Measured: ICU discharge

  3. mortality at hospital discharge

    Measured: hospital discharge

  4. mortality at 6 months

    Measured: 6 months

  5. decision to withhold or withdraw active treatments

    Measured: up to 90 days

  6. Time to wean vasopressor therapy

    Measured: up to 90 days

  7. number of days alive and free of vasopressor therapy

    Measured: up to 90 days

  8. time to achieve an SOFA score of less than 6

    Measured: up to 90 days

  9. number of days alive with a SOFA score < 6 points

    Measured: up to 90 days

  10. time to wean mechanical ventilation

    Measured: up to 90 days

  11. number of days alive and free of mechanical ventilation

    Measured: up to 90 days

  12. Length of intensive care unit and hospital stay

    Measured: up to hospital discharge

  13. acquisition of new infection

    Measured: up to 180 days

  14. new episode of sepsis

    Measured: up to 90 days

  15. new episode of septic shock

    Measured: up to 90 days

  16. bleeding events

    Measured: up to 90 days

  17. neurological sequels at intensive care unit and at hospital discharge and at 90 and 180 days

    Measured: up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2008 (estimated)
  2. Study startMar 2008
  3. Primary completionJun 2015
  4. Study completionJul 2016

Resources

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
Factorial
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,241 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00625209
Sponsor's protocol ID
P070128
Acronym
APROCCHS
Status last verified
Jun 2017
First submitted
19 Feb 2008
Last updated
14 Jun 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Annane D, Buisson CB, Cariou A, Martin C, Misset B, Renault A, Lehmann B, Millul V, Maxime V, Bellissant E; APROCCHSS Investigators for the TRIGGERSEP Network. Design and conduct of the activated protein C and corticosteroids for human septic shock (APROCCHSS) trial. Ann Intensive Care. 2016 Dec;6(1):43. doi: 10.1186/s13613-016-0147-3. Epub 2016 May 6.

    PubMed 27154719
  • Annane D, Timsit JF, Megarbane B, Martin C, Misset B, Mourvillier B, Siami S, Chagnon JL, Constantin JM, Petitpas F, Souweine B, Amathieu R, Forceville X, Charpentier C, Tesniere A, Chastre J, Bohe J, Colin G, Cariou A, Renault A, Brun-Buisson C, Bellissant E; APROCCHSS Trial Investigators. Recombinant human activated protein C for adults with septic shock: a randomized controlled trial. Am J Respir Crit Care Med. 2013 May 15;187(10):1091-7. doi: 10.1164/rccm.201211-2020OC.

    PubMed 23525934
  • Heming N, Renault A, Kuperminc E, Brun-Buisson C, Megarbane B, Quenot JP, Siami S, Cariou A, Forceville X, Schwebel C, Leone M, Timsit JF, Misset B, Benali MA, Colin G, Souweine B, Asehnoune K, Mercier E, Chimot L, Charpentier C, Francois B, Boulain T, Petitpas F, Constantin JM, Dhonneur G, Baudin F, Combes A, Bohe J, Loriferne JF, Cook F, Slama M, Leroy O, Capellier G, Dargent A, Hissem T, Bounab R, Maxime V, Moine P, Bellissant E, Annane D; APROCCHSS investigators; CRICS-TRIGGERSEP network. Hydrocortisone plus fludrocortisone for community acquired pneumonia-related septic shock: a subgroup analysis of the APROCCHSS phase 3 randomised trial. Lancet Respir Med. 2024 May;12(5):366-374. doi: 10.1016/S2213-2600(23)00430-7. Epub 2024 Feb 1.

    PubMed 38310918
  • Annane D, Renault A, Brun-Buisson C, Megarbane B, Quenot JP, Siami S, Cariou A, Forceville X, Schwebel C, Martin C, Timsit JF, Misset B, Ali Benali M, Colin G, Souweine B, Asehnoune K, Mercier E, Chimot L, Charpentier C, Francois B, Boulain T, Petitpas F, Constantin JM, Dhonneur G, Baudin F, Combes A, Bohe J, Loriferne JF, Amathieu R, Cook F, Slama M, Leroy O, Capellier G, Dargent A, Hissem T, Maxime V, Bellissant E; CRICS-TRIGGERSEP Network. Hydrocortisone plus Fludrocortisone for Adults with Septic Shock. N Engl J Med. 2018 Mar 1;378(9):809-818. doi: 10.1056/NEJMoa1705716.

    PubMed 29490185

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing recombinant human activated protein C and hydrocortisone and fludrocortisone in people with Septic Shock, run by University of Versailles at 4 sites 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 6 inclusion and 29 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: finished, as of the sponsor's last update on 14 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

90-day mortality (time frame: 90 day). 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 NCT00625209, which also lists 4 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 14 Jun 2017.

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