Septic ShockNCT06568744
Fluid Intolerance Signals as Safety Limits to Prevent Fluid-induced Harm During Septic Shock Resuscitation
A study testing Intervention resuscitation in people with Septic Shock, run by Pontificia Universidad Catolica de Chile at 3 sites in Chile.
Trial summary
The goal of this multicentric randomized controlled trial is to compare, in septic shock patients who require further fluid resuscitation, two strategies of administering fluids. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Septic Shock
- What is being tested?
- Intervention resuscitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 3 sitesChile
- Study dates
- 22 Aug 2024to Jul 2026
- Phase
- Interventional
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed or suspected septic shock
- < 24 hours since diagnosis
- Hypoperfusion signal (altered arterial lactate or CRT) that requires further resuscitation
- Mechanical ventilation
- Positive fluid responsiveness status
Who cannot join
- Pregnancy
- Do-not-resuscitate status
- Acute coronary syndrome
- Active bleeding
- Severe concomitant acute respiratory distress syndrome (ARDS) (PaO2:FiO2 ratio < 100)
- Anticipated surgery, prone positioning, or renal replacement therapy in the next 6 hours
Show all 9Show fewer
- Refractory shock according to attending physician
- BMI > 40.
- Inadequate echocardiographic window
Trial locations and contacts
3 sites in 1 country.
Chile3 sites, 3 recruiting
- Recruiting
Hospital Biprovincial Quillota-Petorca
Quillota
Roberto Contreras, MD
Roberto Contreras, MD
- Recruiting
Hospital Barros Luco
Santiago
Cesar Santis, MD, csantis05@gmail.com
Giorgio Ferri, MD
- Recruiting
Hospital Clinico UC Christus
Santiago
Eduardo Kattan, MD, PhD, e.kattan@gmail.com
Eduardo Kattan, MD
About this study
The goal of this multicentric randomized controlled trial is to compare, in septic shock patients who require further fluid resuscitation, two strategies of administering fluids. The intervention group will integrate fluid intolerance signals to the decision making process, while the control group will follow standard of care, for a 6 hour study protocol. The main question it aims to answer is
- To compare the effect of both resuscitation strategies on fluid-induced harm, assessed by the change in pulmonary, cardiac, and renal function biomarkers during the study period.
- To assess the safety of both resuscitation strategies on hypoperfusion resolution, measured by the improvement of capillary refill time (CRT) and lactate during the study period.
- To determine the dynamics of the different fluid intolerance signals
Read the detailed description
Fluids are the first-line hemodynamic therapy during septic shock resuscitation, restoring tissue perfusion by effectively increasing cardiac output and oxygen delivery. Nevertheless, resuscitation fluids can be seen as a double-edged sword since they have a narrow therapeutic index. In the one hand, insufficient fluid administration can perpetuate hypoperfusion, leading to irreversible tissue hypoxia, while excessive fluid administration can lead to fluid-induced harm. The extreme scenario of this condition, fluid overload, has been consistently associated with worse clinical outcomes, including increased risks of prolonged mechanical ventilation, acute kidney injury and mortality. As an eminently retrospective diagnosis, it may underestimate the importance of timely recognition of fluid-induced harm during the resuscitation period and could shift clinicians' efforts to treatment rather than prevention. Thus, identifying organ-specific venous congestion signals early on during the resuscitation process is desirable and could avoid these adverse outcomes. Recent studies have shown that venous congestion signals are present even during the first day of ICU admission.
The investigators hypothesized that in critically ill patients with septic shock, a fluid resuscitation strategy that integrates fluid intolerance signals as safety limits will prevent fluid-induced harm, without compromising hypoperfusion resolution, compared to a standard resuscitation strategy.
To confirm this hypothesis, the investigators propose a multicenter prospective randomized controlled study in 62 critically ill patients with septic shock, comparing two strategies for conducting fluid resuscitation, aiming to decrease fluid-induced harm. One strategy will follow the standard of care, while the other will rest on real-time ultrasound-based monitoring of fluid intolerance signals. The latter approach will allow clinicians to limit fluid administration when potentially deleterious signals appear. The impact of both strategies on fluid-induced harm will be assessed by the evolution of key organ function biomarkers, namely lungs, heart, and kidneys during the 6-hour study period. Perfusion dynamics will be assessed by capillary refill time and arterial lactate kinetics during the study period. Patients will receive general monitoring and management according to ICU standards. Patients will be followed-up for 28 days for other relevant outcomes.
- Conditions
- Septic Shock
- Being tested
- Intervention resuscitation, Standard of Care resuscitation
- Keywords
- fluid overload, resuscitation, capillary refill time, POCUS
- Medical subject headings
- Shock, Septic, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention resuscitationOther
In fluid responsive patients, fluid intolerance will be checked.
Lung Ultrasound (LUS): Anterior LUS with 4-point assessment at each hemithorax. Min:0 and a max:24. Low risk: < 10; intermediate risk: 10-14 or delta of 2 points. High risk: >14, or an increase >4 from baseline.
VExUS: Low risk: Grade 0-1. Intermediate risk: 2. High risk: 3 E/e' ratio: Low risk: <8. Intermediate risk: 8-13. High risk >14. Central venous pressure (CVP): Low risk <12 mmHg. Intermediate risk: 12-15 mmHg or a delta of 3 mmHg. High risk > 15 mmHg or >5 mmHg increase after a fluid challenge.
In low-risk, a fluid challenge of 500 ml of balanced crystalloid will be performed in 30 minutes. If intermediate risk, a fluid challenge of 250 ml of balanced crystalloid in 30 minutes. If high-risk signals, alternative strategies (vasopressor and inodilator tests) will be deployed. After each challenge, peripheral perfusion, fluid responsiveness and intolerance will be re-assessed.
Standard of Care resuscitationOther
In fluid responsive patients, fluid challenges of 500 ml of balanced crystalloid will be performed in 30 minutes. After a fluid challenge, peripheral perfusion status and fluid responsiveness will be re-measured. If the patient persists with hypoperfusion, successive fluid challenges will be performed until hypoperfusion resolves or the patient becomes fluid unresponsive. If hypoperfusion signals persists and the patient becomes fluid unresponsive, alternative resuscitation interventions will be deployed, which include: 1) vasopressor titration to higher mean arterial pressure (MAP) targets in a MAP-test, and 2) addition of an inotrope to increase cardiac output in an inodilator test. If hypoperfusion fails to resolve, rescue therapies such as high-volume hemofiltration will be initiated.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | This group will follow a resuscitation algorithm aimed at macrohemodynamic stabilization and improvement of tissue hypoperfusion. Fluid administration will be tailored according to fluid responsiveness status, fluid intolerance signals, and hypoperfusion signals such as capillary refill time. Mechanical ventilation and sedation will follow standard management as per current recommendations. Receives: Other: Intervention resuscitation |
| Standard of Care | Active comparator | This group will follow a resuscitation algorithm aimed at macrohemodynamic stabilization and improvement of tissue hypoperfusion. Fluid administration will be tailored according to fluid responsiveness status, and hypoperfusion signals such as capillary refill time. Mechanical ventilation and sedation will follow standard management as per current recommendations. Receives: Other: Standard of Care resuscitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delta of PaO2: fraction of inspired oxygen (FiO2) ratio between 0-6 hours
evolution of lung function during the study period (6h)
Measured: 6 hours
Secondary outcomes (5)
Delta of proBNP between 0-6 hours
evolution of cardiac function during the study period (6h)
Measured: 6 hours
Delta of plasma neutrophil gelatinase-associated lipocalin (NGAL) between 0-6 hours
evolution of renal function during the study period (6h)
Measured: 6 hours
Delta of creatinine between 0-6 hours
evolution of renal function during the study period (6h)
Measured: 6 hours
Delta of capillary refill time between 0-6 hours
evolution of peripheral perfusion during the study period (6h)
Measured: 6 hours
Delta of arterial lactate between 0-6 hours
evolution of lactate during the study period (6h)
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2024
- Study start22 Aug 2024
- Primary completionMay 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- More trials run by Pontificia Universidad Catolica de ChileThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eduardo Kattan, MD, PhD, Principal investigator, Pontifiia Universidad Catolica de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06568744
- Sponsor's protocol ID
- 220607015
- Other IDs
- 1230475
- Status last verified
- Aug 2024
- First submitted
- 21 Aug 2024
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: data sharing will be anonymized upon reasonable request to the corresponding author
Publications
Munoz F, Born P, Bruna M, Ulloa R, Gonzalez C, Philp V, Mondaca R, Blanco JP, Valenzuela ED, Retamal J, Miralles F, Wendel-Garcia PD, Ospina-Tascon GA, Castro R, Rola P, Bakker J, Hernandez G, Kattan E. Coexistence of a fluid responsive state and venous congestion signals in critically ill patients: a multicenter observational proof-of-concept study. Crit Care. 2024 Feb 19;28(1):52. doi: 10.1186/s13054-024-04834-1.
PubMed 38374167Kenny JS, Prager R, Rola P, Haycock K, Basmaji J, Hernandez G. Unifying Fluid Responsiveness and Tolerance With Physiology: A Dynamic Interpretation of the Diamond-Forrester Classification. Crit Care Explor. 2023 Dec 12;5(12):e1022. doi: 10.1097/CCE.0000000000001022. eCollection 2023 Dec.
PubMed 38094087Kattan E, Castro R, Miralles-Aguiar F, Hernandez G, Rola P. The emerging concept of fluid tolerance: A position paper. J Crit Care. 2022 Oct;71:154070. doi: 10.1016/j.jcrc.2022.154070. Epub 2022 Jun 2.
PubMed 35660844Kattan E, Ospina-Tascon GA, Teboul JL, Castro R, Cecconi M, Ferri G, Bakker J, Hernandez G; ANDROMEDA-SHOCK Investigators. Systematic assessment of fluid responsiveness during early septic shock resuscitation: secondary analysis of the ANDROMEDA-SHOCK trial. Crit Care. 2020 Jan 23;24(1):23. doi: 10.1186/s13054-020-2732-y.
PubMed 31973735Zampieri FG, Damiani LP, Bakker J, Ospina-Tascon GA, Castro R, Cavalcanti AB, Hernandez G. Effects of a Resuscitation Strategy Targeting Peripheral Perfusion Status versus Serum Lactate Levels among Patients with Septic Shock. A Bayesian Reanalysis of the ANDROMEDA-SHOCK Trial. Am J Respir Crit Care Med. 2020 Feb 15;201(4):423-429. doi: 10.1164/rccm.201905-0968OC.
PubMed 31574228Hernandez G, Ospina-Tascon GA, Damiani LP, Estenssoro E, Dubin A, Hurtado J, Friedman G, Castro R, Alegria L, Teboul JL, Cecconi M, Ferri G, Jibaja M, Pairumani R, Fernandez P, Barahona D, Granda-Luna V, Cavalcanti AB, Bakker J; The ANDROMEDA SHOCK Investigators and the Latin America Intensive Care Network (LIVEN); Hernandez G, Ospina-Tascon G, Petri Damiani L, Estenssoro E, Dubin A, Hurtado J, Friedman G, Castro R, Alegria L, Teboul JL, Cecconi M, Cecconi M, Ferri G, Jibaja M, Pairumani R, Fernandez P, Barahona D, Cavalcanti AB, Bakker J, Hernandez G, Alegria L, Ferri G, Rodriguez N, Holger P, Soto N, Pozo M, Bakker J, Cook D, Vincent JL, Rhodes A, Kavanagh BP, Dellinger P, Rietdijk W, Carpio D, Pavez N, Henriquez E, Bravo S, Valenzuela ED, Vera M, Dreyse J, Oviedo V, Cid MA, Larroulet M, Petruska E, Sarabia C, Gallardo D, Sanchez JE, Gonzalez H, Arancibia JM, Munoz A, Ramirez G, Aravena F, Aquevedo A, Zambrano F, Bozinovic M, Valle F, Ramirez M, Rossel V, Munoz P, Ceballos C, Esveile C, Carmona C, Candia E, Mendoza D, Sanchez A, Ponce D, Ponce D, Lastra J, Nahuelpan B, Fasce F, Luengo C, Medel N, Cortes C, Campassi L, Rubatto P, Horna N, Furche M, Pendino JC, Bettini L, Lovesio C, Gonzalez MC, Rodruguez J, Canales H, Caminos F, Galletti C, Minoldo E, Aramburu MJ, Olmos D, Nin N, Tenzi J, Quiroga C, Lacuesta P, Gaudin A, Pais R, Silvestre A, Olivera G, Rieppi G, Berrutti D, Ochoa M, Cobos P, Vintimilla F, Ramirez V, Tobar M, Garcia F, Picoita F, Remache N, Granda V, Paredes F, Barzallo E, Garces P, Guerrero F, Salazar S, Torres G, Tana C, Calahorrano J, Solis F, Torres P, Herrera L, Ornes A, Perez V, Delgado G, Lopez A, Espinosa E, Moreira J, Salcedo B, Villacres I, Suing J, Lopez M, Gomez L, Toctaquiza G, Cadena Zapata M, Orazabal MA, Pardo Espejo R, Jimenez J, Calderon A, Paredes G, Barberan JL, Moya T, Atehortua H, Sabogal R, Ortiz G, Lara A, Sanchez F, Hernan Portilla A, Davila H, Mora JA, Calderon LE, Alvarez I, Escobar E, Bejarano A, Bustamante LA, Aldana JL. Effect of a Resuscitation Strategy Targeting Peripheral Perfusion Status vs Serum Lactate Levels on 28-Day Mortality Among Patients With Septic Shock: The ANDROMEDA-SHOCK Randomized Clinical Trial. JAMA. 2019 Feb 19;321(7):654-664. doi: 10.1001/jama.2019.0071.
PubMed 30772908Bagshaw SM, Brophy PD, Cruz D, Ronco C. Fluid balance as a biomarker: impact of fluid overload on outcome in critically ill patients with acute kidney injury. Crit Care. 2008;12(4):169. doi: 10.1186/cc6948. Epub 2008 Jul 24.
PubMed 18671831
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluid Intolerance Signals as Safety Limits to Prevent Fluid-induced Harm During Septic Shock Resuscitation
- ClinicalTrials.gov ID
- NCT06568744
- Acronym / sponsor ID
- 220607015
- Conditions
- Septic Shock
- Keywords
- fluid overload, resuscitation, capillary refill time, POCUS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Study start
- 22 Aug 2024 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 23 Aug 2024 (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.
The goal of this multicentric randomized controlled trial is to compare, in septic shock patients who require further fluid resuscitation, two strategies of administering fluids. The intervention group will integrate fluid intolerance signals to the decision making process, while the control group will follow standard of care, for a 6 hour study protocol. The main question it aims to answer is
- To compare the effect of both resuscitation strategies on fluid-induced harm, assessed by the change in pulmonary, cardiac, and renal function biomarkers during the study period.
- To assess the safety of both resuscitation strategies on hypoperfusion resolution, measured by the improvement of capillary refill time (CRT) and lactate during the study period.
- To determine the dynamics of the different fluid intolerance signals
Detailed description
Fluids are the first-line hemodynamic therapy during septic shock resuscitation, restoring tissue perfusion by effectively increasing cardiac output and oxygen delivery. Nevertheless, resuscitation fluids can be seen as a double-edged sword since they have a narrow therapeutic index. In the one hand, insufficient fluid administration can perpetuate hypoperfusion, leading to irreversible tissue hypoxia, while excessive fluid administration can lead to fluid-induced harm. The extreme scenario of this condition, fluid overload, has been consistently associated with worse clinical outcomes, including increased risks of prolonged mechanical ventilation, acute kidney injury and mortality. As an eminently retrospective diagnosis, it may underestimate the importance of timely recognition of fluid-induced harm during the resuscitation period and could shift clinicians' efforts to treatment rather than prevention. Thus, identifying organ-specific venous congestion signals early on during the resuscitation process is desirable and could avoid these adverse outcomes. Recent studies have shown that venous congestion signals are present even during the first day of ICU admission.
The investigators hypothesized that in critically ill patients with septic shock, a fluid resuscitation strategy that integrates fluid intolerance signals as safety limits will prevent fluid-induced harm, without compromising hypoperfusion resolution, compared to a standard resuscitation strategy.
To confirm this hypothesis, the investigators propose a multicenter prospective randomized controlled study in 62 critically ill patients with septic shock, comparing two strategies for conducting fluid resuscitation, aiming to decrease fluid-induced harm. One strategy will follow the standard of care, while the other will rest on real-time ultrasound-based monitoring of fluid intolerance signals. The latter approach will allow clinicians to limit fluid administration when potentially deleterious signals appear. The impact of both strategies on fluid-induced harm will be assessed by the evolution of key organ function biomarkers, namely lungs, heart, and kidneys during the 6-hour study period. Perfusion dynamics will be assessed by capillary refill time and arterial lactate kinetics during the study period. Patients will receive general monitoring and management according to ICU standards. Patients will be followed-up for 28 days for other relevant outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Intervention resuscitationThis group will follow a resuscitation algorithm aimed at macrohemodynamic stabilization and improvement of tissue hypoperfusion. Fluid administration will be tailored according to fluid responsiveness status, fluid intolerance signals, and hypoperfusion signals such as capillary refill time. Mechanical ventilation and sedation will follow standard management as per current recommendations. |
| Standard of Care | Active comparator | Other: Standard of Care resuscitationThis group will follow a resuscitation algorithm aimed at macrohemodynamic stabilization and improvement of tissue hypoperfusion. Fluid administration will be tailored according to fluid responsiveness status, and hypoperfusion signals such as capillary refill time. Mechanical ventilation and sedation will follow standard management as per current recommendations. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed or suspected septic shock
- < 24 hours since diagnosis
- Hypoperfusion signal (altered arterial lactate or CRT) that requires further resuscitation
- Mechanical ventilation
- Positive fluid responsiveness status
Key exclusion criteria (9 listed)
- Pregnancy
- Do-not-resuscitate status
- Acute coronary syndrome
- Active bleeding
- Severe concomitant acute respiratory distress syndrome (ARDS) (PaO2:FiO2 ratio < 100)
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 |
|---|---|---|
| Intervention resuscitationIn fluid responsive patients, fluid intolerance will be checked. Lung Ultrasound (LUS): Anterior LUS with 4-point assessment at each hemithorax. Min:0 and a max:24. Low risk: < 10; intermediate risk: 10-14 or delta of 2 points. High risk: >14, or an increase >4 from baseline. VExUS: Low risk: Grade 0-1. Intermediate risk: 2. High risk: 3 E/e' ratio: Low risk: <8. Intermediate risk: 8-13. High risk >14. Central venous pressure (CVP): Low risk <12 mmHg. Intermediate risk: 12-15 mmHg or a delta of 3 mmHg. High risk > 15 mmHg or >5 mmHg increase after a fluid challenge. In low-risk, a fluid challenge of 500 ml of balanced crystalloid will be performed in 30 minutes. If intermediate risk, a fluid challenge of 250 ml of balanced crystalloid in 30 minutes. If high-risk signals, alternative strategies (vasopressor and inodilator tests) will be deployed. After each challenge, peripheral perfusion, fluid responsiveness and intolerance will be re-assessed. | Other | Intervention |
| Standard of Care resuscitationIn fluid responsive patients, fluid challenges of 500 ml of balanced crystalloid will be performed in 30 minutes. After a fluid challenge, peripheral perfusion status and fluid responsiveness will be re-measured. If the patient persists with hypoperfusion, successive fluid challenges will be performed until hypoperfusion resolves or the patient becomes fluid unresponsive. If hypoperfusion signals persists and the patient becomes fluid unresponsive, alternative resuscitation interventions will be deployed, which include: 1) vasopressor titration to higher mean arterial pressure (MAP) targets in a MAP-test, and 2) addition of an inotrope to increase cardiac output in an inodilator test. If hypoperfusion fails to resolve, rescue therapies such as high-volume hemofiltration will be initiated. | Other | Standard of Care |
Primary outcome
Delta of PaO2: fraction of inspired oxygen (FiO2) ratio between 0-6 hours
Time frame: 6 hours
evolution of lung function during the study period (6h)
5 secondary outcomes
Delta of proBNP between 0-6 hours
Time frame: 6 hours
Delta of plasma neutrophil gelatinase-associated lipocalin (NGAL) between 0-6 hours
Time frame: 6 hours
Delta of creatinine between 0-6 hours
Time frame: 6 hours
Delta of capillary refill time between 0-6 hours
Time frame: 6 hours
Delta of arterial lactate between 0-6 hours
Time frame: 6 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
- Background: PubMed 38374167Munoz F, Born P, Bruna M, Ulloa R, Gonzalez C, Philp V, Mondaca R, Blanco JP, Valenzuela ED, Retamal J, Miralles F, Wendel-Garcia PD, Ospina-Tascon GA, Castro R, Rola P, Bakker J, Hernandez G, Kattan E. Coexistence of a fluid responsive state and venous congestion signals in critically ill patients: a multicenter observational proof-of-concept study. Crit Care. 2024 Feb 19;28(1):52. doi: 10.1186/s13054-024-04834-1.
- Background: PubMed 38094087Kenny JS, Prager R, Rola P, Haycock K, Basmaji J, Hernandez G. Unifying Fluid Responsiveness and Tolerance With Physiology: A Dynamic Interpretation of the Diamond-Forrester Classification. Crit Care Explor. 2023 Dec 12;5(12):e1022. doi: 10.1097/CCE.0000000000001022. eCollection 2023 Dec.
- Background: PubMed 35660844Kattan E, Castro R, Miralles-Aguiar F, Hernandez G, Rola P. The emerging concept of fluid tolerance: A position paper. J Crit Care. 2022 Oct;71:154070. doi: 10.1016/j.jcrc.2022.154070. Epub 2022 Jun 2.
- Background: PubMed 31973735Kattan E, Ospina-Tascon GA, Teboul JL, Castro R, Cecconi M, Ferri G, Bakker J, Hernandez G; ANDROMEDA-SHOCK Investigators. Systematic assessment of fluid responsiveness during early septic shock resuscitation: secondary analysis of the ANDROMEDA-SHOCK trial. Crit Care. 2020 Jan 23;24(1):23. doi: 10.1186/s13054-020-2732-y.
- Background: PubMed 31574228Zampieri FG, Damiani LP, Bakker J, Ospina-Tascon GA, Castro R, Cavalcanti AB, Hernandez G. Effects of a Resuscitation Strategy Targeting Peripheral Perfusion Status versus Serum Lactate Levels among Patients with Septic Shock. A Bayesian Reanalysis of the ANDROMEDA-SHOCK Trial. Am J Respir Crit Care Med. 2020 Feb 15;201(4):423-429. doi: 10.1164/rccm.201905-0968OC.
- Background: PubMed 30772908Hernandez G, Ospina-Tascon GA, Damiani LP, Estenssoro E, Dubin A, Hurtado J, Friedman G, Castro R, Alegria L, Teboul JL, Cecconi M, Ferri G, Jibaja M, Pairumani R, Fernandez P, Barahona D, Granda-Luna V, Cavalcanti AB, Bakker J; The ANDROMEDA SHOCK Investigators and the Latin America Intensive Care Network (LIVEN); Hernandez G, Ospina-Tascon G, Petri Damiani L, Estenssoro E, Dubin A, Hurtado J, Friedman G, Castro R, Alegria L, Teboul JL, Cecconi M, Cecconi M, Ferri G, Jibaja M, Pairumani R, Fernandez P, Barahona D, Cavalcanti AB, Bakker J, Hernandez G, Alegria L, Ferri G, Rodriguez N, Holger P, Soto N, Pozo M, Bakker J, Cook D, Vincent JL, Rhodes A, Kavanagh BP, Dellinger P, Rietdijk W, Carpio D, Pavez N, Henriquez E, Bravo S, Valenzuela ED, Vera M, Dreyse J, Oviedo V, Cid MA, Larroulet M, Petruska E, Sarabia C, Gallardo D, Sanchez JE, Gonzalez H, Arancibia JM, Munoz A, Ramirez G, Aravena F, Aquevedo A, Zambrano F, Bozinovic M, Valle F, Ramirez M, Rossel V, Munoz P, Ceballos C, Esveile C, Carmona C, Candia E, Mendoza D, Sanchez A, Ponce D, Ponce D, Lastra J, Nahuelpan B, Fasce F, Luengo C, Medel N, Cortes C, Campassi L, Rubatto P, Horna N, Furche M, Pendino JC, Bettini L, Lovesio C, Gonzalez MC, Rodruguez J, Canales H, Caminos F, Galletti C, Minoldo E, Aramburu MJ, Olmos D, Nin N, Tenzi J, Quiroga C, Lacuesta P, Gaudin A, Pais R, Silvestre A, Olivera G, Rieppi G, Berrutti D, Ochoa M, Cobos P, Vintimilla F, Ramirez V, Tobar M, Garcia F, Picoita F, Remache N, Granda V, Paredes F, Barzallo E, Garces P, Guerrero F, Salazar S, Torres G, Tana C, Calahorrano J, Solis F, Torres P, Herrera L, Ornes A, Perez V, Delgado G, Lopez A, Espinosa E, Moreira J, Salcedo B, Villacres I, Suing J, Lopez M, Gomez L, Toctaquiza G, Cadena Zapata M, Orazabal MA, Pardo Espejo R, Jimenez J, Calderon A, Paredes G, Barberan JL, Moya T, Atehortua H, Sabogal R, Ortiz G, Lara A, Sanchez F, Hernan Portilla A, Davila H, Mora JA, Calderon LE, Alvarez I, Escobar E, Bejarano A, Bustamante LA, Aldana JL. Effect of a Resuscitation Strategy Targeting Peripheral Perfusion Status vs Serum Lactate Levels on 28-Day Mortality Among Patients With Septic Shock: The ANDROMEDA-SHOCK Randomized Clinical Trial. JAMA. 2019 Feb 19;321(7):654-664. doi: 10.1001/jama.2019.0071.
- Background: PubMed 18671831Bagshaw SM, Brophy PD, Cruz D, Ronco C. Fluid balance as a biomarker: impact of fluid overload on outcome in critically ill patients with acute kidney injury. Crit Care. 2008;12(4):169. doi: 10.1186/cc6948. Epub 2008 Jul 24.
- Individual participant dataSharing planned: Yes. data sharing will be anonymized upon reasonable request to the corresponding author
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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.
Eduardo Kattan, MD, PhD principal investigator
Pontifiia Universidad Catolica de Chile
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention resuscitation in people with Septic Shock, run by Pontificia Universidad Catolica de Chile at 3 sites in Chile.
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 9 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: status not confirmed, as of the sponsor's last update on 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Chile. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eduardo Kattan, MD, PhD (+56223543292, e.kattan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delta of PaO2: fraction of inspired oxygen (FiO2) ratio between 0-6 hours (time frame: 6 hours). 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 NCT06568744, which also lists 7 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 2 Oct 2024.