HemorrhageCRIHEMNCT02701725
Compensatory Reserve Index as a Hemodynamic Status Evaluation Tool in Patients
An observational study of Hemorrhage and Sepsis, run by Meir Medical Center.
Trial summary
The investigators will use the Compensatory Reserve Index (CRI) device to monitor hemodynamic status of patients in the hospital. CRI values of patients will be monitored during their care in order to verify the compliance of the values to the physiological condition. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemorrhage, Sepsis
- What is being tested?
- CRI status
- Type of treatment
- Medical device
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Sep 2016
- Phase
- Observational
- 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
Study population: A prospective Review of all adult patients admitted to Meir Medical Center who meet criteria.
Who may be able to join
- All patients with blood loss (trauma or disease)
- All patients receiving blood products of any type
- All patients with SIRS or Sepsis
- All patients who are anticipated to suffer for sepsis
Who cannot join
- Under 18 years old
Trial locations and contacts
No sites are listed yet.
About this study
The investigators will use the Compensatory Reserve Index (CRI) device to monitor hemodynamic status of patients in the hospital. CRI values of patients will be monitored during their care in order to verify the compliance of the values to the physiological condition. During the protocol investigators will document patients injuries, life-saving procedures performed, response to treatment as well progress to systemic inflammatory response syndrome (SIRS) and sepsis.
The indices measured in the study will not be a consideration when handling patients. The medical team will not be exposed to metrics measured.
Read the detailed description
Assessment of patients in the emergency department, ICU or surgical department can be a challenging process. This assessment includes collecting data regarding injury mechanism, vital signs, and physical examination findings before proceeding to other ways of evaluating the patient.
These data are then integrated in an attempt to form an accurate patient status and to determine the urgency of treatment and evacuation to the next echelon of care when necessary. When caring for multiple casualties, this process takes on an even greater importance because the care of one patient can delay the care of others.
Triage and monitoring of patients consists of several vital sign measurements including blood pressure, oxygen saturation, and heart rate. These measurements show varying correlation with patient survival, Injury Severity Score, and the need for life-saving intervention. The most significant disadvantage of their use as part of patient triage is that they are all retrospective by nature, and a change in these indices occur only after substantial hemodynamic compromise and failure of compensatory mechanisms when life-saving interventions might be too late.
Because of the limitations inherent to these vital signs, several calculated indices have been suggested in an attempt to integrate a few vital signs into more sensitive metrics for prediction of patient outcomes. The most frequently described metric is shock index (SI), which is calculated as the ratio between heart rate and systolic blood pressure (normal values, 0.5 Y 0.7), and has demonstrated superiority over other indices. Heart rate variability has also been frequently suggested as a calculated vital sign, but its clinical utility in the acute blood loss setting has proven to be limited as a result of its high interpatient and intrapatient variability.
The Compensatory Reserve Index (CRI) represents a new paradigm for measuring the physiological reserve of integrated cardiopulmonary mechanisms (e.g., tachycardia, vasoconstriction, breathing) that compensate for reduced central blood volume. Advanced sensor technologies such as photoplethysmography enable noninvasive recordings of analog arterial waveforms. Using a model that induces stepwise reduction of central blood volume (lower body negative pressure [LBNP]) in volunteering young healthy human test subjects, through application of negative pressure to the lower body, feature-extraction and machine-learning techniques were used to reveal subtle changes in waveform features that are associated with a declining volume. This approach enables simultaneous abstraction and normalization of various characteristics of the arterial waveform. As such, the CRI aims to reflect the capacity of all factors contributing to physiological compensatory mechanisms, including compensatory reflexes, various muscle contractions, and respirations, among others. Compensatory Reserve Index values range from 0 (complete decompensation) to 1 (full compensatory reserve available). The device itself is compact, light, and can be placed on the patient's finger, and the test can be performed within 30 s, making the measurement of CRI theoretically feasible in almost any setting. The approach was designed to prospectively identify ongoing loss of central blood volume and thus estimate the point at which individuals will experience hemodynamic decompensation (onset of shock) well in advance compared with changes in standard or "legacy" vital signs.
The CRI has been shown to correlate with central blood volume changes in human subjects in laboratory conditions however, few published data regarding its use in other experimental models or its ability to detect actual blood loss exist. The current investigation represents the first effort to apply a small pulse oximeter unit to test the CRI on human subjects admitted to hospital.
The purpose of the study is to test the hypothesis that a novel noninvasive CRI monitoring algorithm would demonstrate greater sensitivity and specificity compared with standard vital signs for identifying patients with blood loss, SIRS, sepsis thus enabling appropriate measures to be taken.
- Conditions
- Hemorrhage, Sepsis
- Being tested
- CRI status
- Medical subject headings
- Hemorrhage, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRI statusDevice
Measurement of CRI
What is being measured
The primary outcome is the main question the study is designed to answer.
change in CRI
Measured: 6 m
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionMay 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for HemorrhageStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02701725
- Sponsor's protocol ID
- 0260-15-MMC
- Acronym
- CRIHEM
- Status last verified
- Feb 2016
- First submitted
- 1 Mar 2016
- Last updated
- 9 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
King DR, Ogilvie MP, Pereira BM, Chang Y, Manning RJ, Conner JA, Schulman CI, McKenney MG, Proctor KG. Heart rate variability as a triage tool in patients with trauma during prehospital helicopter transport. J Trauma. 2009 Sep;67(3):436-40. doi: 10.1097/TA.0b013e3181ad67de.
PubMed 19741382Convertino VA, Ryan KL, Rickards CA, Salinas J, McManus JG, Cooke WH, Holcomb JB. Physiological and medical monitoring for en route care of combat casualties. J Trauma. 2008 Apr;64(4 Suppl):S342-53. doi: 10.1097/TA.0b013e31816c82f4.
PubMed 18385586Soller BR, Zou F, Ryan KL, Rickards CA, Ward K, Convertino VA. Lightweight noninvasive trauma monitor for early indication of central hypovolemia and tissue acidosis: a review. J Trauma Acute Care Surg. 2012 Aug;73(2 Suppl 1):S106-11. doi: 10.1097/TA.0b013e318260a928.
PubMed 22847078Bruijns SR, Guly HR, Bouamra O, Lecky F, Lee WA. The value of traditional vital signs, shock index, and age-based markers in predicting trauma mortality. J Trauma Acute Care Surg. 2013 Jun;74(6):1432-7. doi: 10.1097/TA.0b013e31829246c7.
PubMed 23694869Moulton SL, Mulligan J, Grudic GZ, Convertino VA. Running on empty? The compensatory reserve index. J Trauma Acute Care Surg. 2013 Dec;75(6):1053-9. doi: 10.1097/TA.0b013e3182aa811a.
PubMed 24256681Birkhahn RH, Gaeta TJ, Terry D, Bove JJ, Tloczkowski J. Shock index in diagnosing early acute hypovolemia. Am J Emerg Med. 2005 May;23(3):323-6. doi: 10.1016/j.ajem.2005.02.029.
PubMed 15915406Rixen D, Siegel JH, Friedman HP. "Sepsis/SIRS," physiologic classification, severity stratification, relation to cytokine elaboration and outcome prediction in posttrauma critical illness. J Trauma. 1996 Oct;41(4):581-98. doi: 10.1097/00005373-199610000-00001.
PubMed 8858015Convertino VA, Howard JT, Hinojosa-Laborde C, Cardin S, Batchelder P, Mulligan J, Grudic GZ, Moulton SL, MacLeod DB. Individual-Specific, Beat-to-beat Trending of Significant Human Blood Loss: The Compensatory Reserve. Shock. 2015 Aug;44 Suppl 1:27-32. doi: 10.1097/SHK.0000000000000323.
PubMed 25565640Nadler R, Convertino VA, Gendler S, Lending G, Lipsky AM, Cardin S, Lowenthal A, Glassberg E. The value of noninvasive measurement of the compensatory reserve index in monitoring and triage of patients experiencing minimal blood loss. Shock. 2014 Aug;42(2):93-8. doi: 10.1097/SHK.0000000000000178.
PubMed 24667628
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compensatory Reserve Index as a Hemodynamic Status Evaluation Tool in Patients
- ClinicalTrials.gov ID
- NCT02701725
- Acronym / sponsor ID
- CRIHEM / 0260-15-MMC
- Conditions
- Hemorrhage, Sepsis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- May 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 8 Mar 2016 (estimated)
- 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 investigators will use the Compensatory Reserve Index (CRI) device to monitor hemodynamic status of patients in the hospital. CRI values of patients will be monitored during their care in order to verify the compliance of the values to the physiological condition. During the protocol investigators will document patients injuries, life-saving procedures performed, response to treatment as well progress to systemic inflammatory response syndrome (SIRS) and sepsis.
The indices measured in the study will not be a consideration when handling patients. The medical team will not be exposed to metrics measured.
Detailed description
Assessment of patients in the emergency department, ICU or surgical department can be a challenging process. This assessment includes collecting data regarding injury mechanism, vital signs, and physical examination findings before proceeding to other ways of evaluating the patient.
These data are then integrated in an attempt to form an accurate patient status and to determine the urgency of treatment and evacuation to the next echelon of care when necessary. When caring for multiple casualties, this process takes on an even greater importance because the care of one patient can delay the care of others.
Triage and monitoring of patients consists of several vital sign measurements including blood pressure, oxygen saturation, and heart rate. These measurements show varying correlation with patient survival, Injury Severity Score, and the need for life-saving intervention. The most significant disadvantage of their use as part of patient triage is that they are all retrospective by nature, and a change in these indices occur only after substantial hemodynamic compromise and failure of compensatory mechanisms when life-saving interventions might be too late.
Because of the limitations inherent to these vital signs, several calculated indices have been suggested in an attempt to integrate a few vital signs into more sensitive metrics for prediction of patient outcomes. The most frequently described metric is shock index (SI), which is calculated as the ratio between heart rate and systolic blood pressure (normal values, 0.5 Y 0.7), and has demonstrated superiority over other indices. Heart rate variability has also been frequently suggested as a calculated vital sign, but its clinical utility in the acute blood loss setting has proven to be limited as a result of its high interpatient and intrapatient variability.
The Compensatory Reserve Index (CRI) represents a new paradigm for measuring the physiological reserve of integrated cardiopulmonary mechanisms (e.g., tachycardia, vasoconstriction, breathing) that compensate for reduced central blood volume. Advanced sensor technologies such as photoplethysmography enable noninvasive recordings of analog arterial waveforms. Using a model that induces stepwise reduction of central blood volume (lower body negative pressure [LBNP]) in volunteering young healthy human test subjects, through application of negative pressure to the lower body, feature-extraction and machine-learning techniques were used to reveal subtle changes in waveform features that are associated with a declining volume. This approach enables simultaneous abstraction and normalization of various characteristics of the arterial waveform. As such, the CRI aims to reflect the capacity of all factors contributing to physiological compensatory mechanisms, including compensatory reflexes, various muscle contractions, and respirations, among others. Compensatory Reserve Index values range from 0 (complete decompensation) to 1 (full compensatory reserve available). The device itself is compact, light, and can be placed on the patient's finger, and the test can be performed within 30 s, making the measurement of CRI theoretically feasible in almost any setting. The approach was designed to prospectively identify ongoing loss of central blood volume and thus estimate the point at which individuals will experience hemodynamic decompensation (onset of shock) well in advance compared with changes in standard or "legacy" vital signs.
The CRI has been shown to correlate with central blood volume changes in human subjects in laboratory conditions however, few published data regarding its use in other experimental models or its ability to detect actual blood loss exist. The current investigation represents the first effort to apply a small pulse oximeter unit to test the CRI on human subjects admitted to hospital.
The purpose of the study is to test the hypothesis that a novel noninvasive CRI monitoring algorithm would demonstrate greater sensitivity and specificity compared with standard vital signs for identifying patients with blood loss, SIRS, sepsis thus enabling appropriate measures to be taken.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A prospective Review of all adult patients admitted to Meir Medical Center who meet criteria.
Key inclusion criteria (4 listed)
- All patients with blood loss (trauma or disease)
- All patients receiving blood products of any type
- All patients with SIRS or Sepsis
- All patients who are anticipated to suffer for sepsis
Key exclusion criteria (1 listed)
- Under 18 years old
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 |
|---|---|---|
| CRI statusMeasurement of CRI | Device | – |
Primary outcome
change in CRI
Time frame: 6 m
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2016.
- Background: PubMed 19741382King DR, Ogilvie MP, Pereira BM, Chang Y, Manning RJ, Conner JA, Schulman CI, McKenney MG, Proctor KG. Heart rate variability as a triage tool in patients with trauma during prehospital helicopter transport. J Trauma. 2009 Sep;67(3):436-40. doi: 10.1097/TA.0b013e3181ad67de.
- Background: PubMed 18385586Convertino VA, Ryan KL, Rickards CA, Salinas J, McManus JG, Cooke WH, Holcomb JB. Physiological and medical monitoring for en route care of combat casualties. J Trauma. 2008 Apr;64(4 Suppl):S342-53. doi: 10.1097/TA.0b013e31816c82f4.
- Background: PubMed 22847078Soller BR, Zou F, Ryan KL, Rickards CA, Ward K, Convertino VA. Lightweight noninvasive trauma monitor for early indication of central hypovolemia and tissue acidosis: a review. J Trauma Acute Care Surg. 2012 Aug;73(2 Suppl 1):S106-11. doi: 10.1097/TA.0b013e318260a928.
- Background: PubMed 23694869Bruijns SR, Guly HR, Bouamra O, Lecky F, Lee WA. The value of traditional vital signs, shock index, and age-based markers in predicting trauma mortality. J Trauma Acute Care Surg. 2013 Jun;74(6):1432-7. doi: 10.1097/TA.0b013e31829246c7.
- Background: PubMed 24256681Moulton SL, Mulligan J, Grudic GZ, Convertino VA. Running on empty? The compensatory reserve index. J Trauma Acute Care Surg. 2013 Dec;75(6):1053-9. doi: 10.1097/TA.0b013e3182aa811a.
- Background: PubMed 15915406Birkhahn RH, Gaeta TJ, Terry D, Bove JJ, Tloczkowski J. Shock index in diagnosing early acute hypovolemia. Am J Emerg Med. 2005 May;23(3):323-6. doi: 10.1016/j.ajem.2005.02.029.
- Background: PubMed 8858015Rixen D, Siegel JH, Friedman HP. "Sepsis/SIRS," physiologic classification, severity stratification, relation to cytokine elaboration and outcome prediction in posttrauma critical illness. J Trauma. 1996 Oct;41(4):581-98. doi: 10.1097/00005373-199610000-00001.
- Background: PubMed 25565640Convertino VA, Howard JT, Hinojosa-Laborde C, Cardin S, Batchelder P, Mulligan J, Grudic GZ, Moulton SL, MacLeod DB. Individual-Specific, Beat-to-beat Trending of Significant Human Blood Loss: The Compensatory Reserve. Shock. 2015 Aug;44 Suppl 1:27-32. doi: 10.1097/SHK.0000000000000323.
- Background: PubMed 24667628Nadler R, Convertino VA, Gendler S, Lending G, Lipsky AM, Cardin S, Lowenthal A, Glassberg E. The value of noninvasive measurement of the compensatory reserve index in monitoring and triage of patients experiencing minimal blood loss. Shock. 2014 Aug;42(2):93-8. doi: 10.1097/SHK.0000000000000178.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemorrhage and Sepsis, run by Meir Medical Center.
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 4 inclusion and 1 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 9 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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 Avi Benov, M.D M.H.A (97297472501, avi.benov@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in CRI (time frame: 6 m). 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 NCT02701725, which also lists 9 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 9 Mar 2016.