SepsisNCT06067516
Effects of Fluid Resuscitation on Capillary Refilling Time and Organ Functions in Septic Shock
An observational study of Sepsis, run by Samsun University at 1 site in Turkey (Türkiye).
Trial summary
Since the ultimate target of resuscitation is the microcirculation, normal microcirculatory perfusion appears to be the primary target of ideal resuscitation in septic shock patients. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Sepsis
- What is being tested?
- Fluid resuscitations
- Type of treatment
- Injection or infusion
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Oct 2023to 5 Jan 2026
- 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 to 90 years
- All sexes
- Adult, Older adult
Study population: Patients admitted to intensive care due to sepsis and septic shock.
Who may be able to join
- Over 18 years old
- Admitted to intensive care with a diagnosis of sepsis or septic shock
- Systolic blood pressure < 90 mmHg or Mean blood pressure < 65 mmHg
- Those who need vasopressor medication
- Urine output < 0.5 ml/kg/h for at least two hours
- Tachycardia (Heart rate > 100/min)
- Serum Lactate > 2 mmol/L
- Patients with central venous oxygen saturation (ScvO) < 70%
Who cannot join
- Not approved by the patient or his/her guardian
- Known heart, kidney, liver failure
- The initial cause of shock is neurogenic, cardiogenic or obstructive shock.
- Pregnancy or suspected pregnancy
- Those with amputation or severe organ ischemia
- Those with peripheral artery disease
- Cannot be evaluated optimally with transthoracic echo
- Patients who died in the first 24 hours
Trial locations and contacts
1 site in 1 country.
About this study
Since the ultimate target of resuscitation is the microcirculation, normal microcirculatory perfusion appears to be the primary target of ideal resuscitation in septic shock patients. In septic shock patients, microcirculation of the skin may be impaired in the early period due to early sympathetic nervous system activation.
Assessment of skin perfusion has also become popular in shock resuscitation because it is easily accessible for clinical assessment. Studies in septic shock patients, showed that capillary refill time correlated with lactate levels measured at 6 hours of resuscitation and was associated with mortality. Additionally, early normalization of capillary refill time has been associated with improved survival in septic shock This study aimed to evaluate the relationship between the change in capillary filling time (microcirculation) and organ perfusion after fluid resuscitation in sepsis patients in intensive care.
Read the detailed description
An aggressive approach to fluid resuscitation in patients with sepsis is recommended by international guidelines and is considered the cornerstone of treatment. This approach is based on historical concepts and the theory that septic shock is a form of hypovolemic shock characterized by tissue hypoperfusion.
Studies show that capillary refill time is a valuable method to measure the severity of acute disease both in the early and late stages. However, it remains unclear why abnormal peripheral perfusion increases morbidity and mortality. Because from a pathophysiological point of view, the main purpose of activation of the sympathetic nervous system is to maintain the perfusion of vital organs (brain, heart, lung).
The Sequential Organ Failure Assessment (SOFA) score is a simple and objective score that allows for calculation of both the number and the severity of organ dysfunction in six organ systems (respiratory, coagulatory, liver, cardiovascular, renal, and neurologic) and the score can measure individual or aggregate organ dysfunction.
This study aimed to evaluate the relationship between the change in capillary filling time (microcirculation) and SOFA score (organ perfusion) after fluid resuscitation in sepsis patients in intensive care.
After the first admission to the intensive care unit [T0 (baseline)], demographic information of the patients, source of sepsis, Sequential Organ Failure Assessment (SOFA) score, which shows the severity of the disease, Acute Physiology and Chronic Health Evaluation (APACHE II) score, additional systemic diseases, hemodynamic variables, blood gas parameters, and transthoracic echocardiogram findings will be recorded.
Capillary refill time (CRT) will be measured by applying pressure to the index finger for 15 seconds.
As recommended in the Surviving Sepsis Campaign Guidelines, after 30 mL/kg/3 hours crystalloid infusion (T1) and 24 hours (T2), Sequential Organ Failure Assessment (SOFA) score, hemodynamic variables, blood gas parameters, transthoracic echocardiogram findings and capillary refill time will be recorded again.
Patients will be divided into two groups; If the CRT measured at T1 decreased equal to or more than 25% compared to the CRT measured at T0, the patients as responders to capillary refill time (Group CRT-R); If the CRT measured at T1 decreased by less than 25% compared to the CRT measured at T0, the patients as non-responders to capillary refill time (Group CRT-NR) The effect of 30 mL/kg/3 hours crystalloid infusion on peripheral perfusion (in Group CRT-R and Group CRT-NR, which are divided into two by CRT measurement at T0 and T1 times) and the effect on the SOFA scores will be compared.
- Conditions
- Sepsis
- Being tested
- Fluid resuscitations
- Keywords
- Sepsis, Fluid resuscitation, Capillary refill time, Sequential Organ Failure Assessment
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluid resuscitationsOther
In line with the recommendations in the Surviving Sepsis Guide, fingertip capillary refill time (CRT) will be measured by applying pressure to the index finger for 15 seconds in the T1 time period after 30 mL/kg/3 hours crystalloid infusion.
| Study group | Role | What they receive |
|---|---|---|
| Group CRT-R | If the CRT measured at T1 decreased equal to or more than 25% compared to the CRT measured at T0 Receives: Other: Fluid resuscitations | |
| Group CRT-NR | If the CRT measured at T1 decreased by less than 25% compared to the CRT measured at T0 Receives: Other: Fluid resuscitations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sequential organ failure assessment score
The sequential organ failure assessment score, previously known as the sepsis-related organ failure assessment score, is used to track a person's status during the stay in an intensive care unit to determine the extent of a person's organ function or rate of failure. The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems. Each organ system is assigned a point value from 0 (normal) to 4 (high degree of dysfunction/failure). Total the Sequential organ failure assessment score ranges from 0 to 24. The Sequential organ failure assessment score is 0 to 6: mortality < 10%, 7 to 9: mortality 5 - 20%. 10 to 12: mortality 40 - 50%, 13 to 14: mortality 50 - 60%, 15: mortality > 80%, 15 to 24: mortality > 90%. The sequential organ failure assessment score changes after fluid loading (normal value sequential organ failure assessment score < 2).
Measured: up to 24 hours
Secondary outcomes (2)
Stroke volume
Stroke volume is the volume of blood pumped from the left ventricle per beat. Stroke volume is calculated using measurements of ventricle volumes from an echocardiogram and subtracting the volume of the blood in the ventricle at the end of a beat. Stroke volume change after fluid loading (normal value stroke volume 50 to 100 mL.)
Measured: up to 24 hours
Cardiac output
Cardiac output is the amount of blood pumped by the heart minute and is the mechanism whereby blood flows around the body, especially providing blood flow to the brain and other vital organs. Cardiac output change after fluid loading (normal value stroke volume 5-6 L/min.)
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start25 Oct 2023
- Primary completion5 Jan 2026
- Study completion5 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsun University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- OZGUR KOMURCU, 1, Principal investigator, Samsun University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06067516
- Sponsor's protocol ID
- SUKAEK-2023 15/14
- Status last verified
- Jun 2025
- First submitted
- 14 Sep 2023
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Jacquet-Lagreze M, Bouhamri N, Portran P, Schweizer R, Baudin F, Lilot M, Fornier W, Fellahi JL. Capillary refill time variation induced by passive leg raising predicts capillary refill time response to volume expansion. Crit Care. 2019 Aug 16;23(1):281. doi: 10.1186/s13054-019-2560-0.
PubMed 31420052Lara B, Enberg L, Ortega M, Leon P, Kripper C, Aguilera P, Kattan E, Castro R, Bakker J, Hernandez G. Capillary refill time during fluid resuscitation in patients with sepsis-related hyperlactatemia at the emergency department is related to mortality. PLoS One. 2017 Nov 27;12(11):e0188548. doi: 10.1371/journal.pone.0188548. eCollection 2017.
PubMed 29176794Brunauer A, Kokofer A, Bataar O, Gradwohl-Matis I, Dankl D, Bakker J, Dunser MW. Changes in peripheral perfusion relate to visceral organ perfusion in early septic shock: A pilot study. J Crit Care. 2016 Oct;35:105-9. doi: 10.1016/j.jcrc.2016.05.007. Epub 2016 May 12.
PubMed 27481743Monnet X, Shi R, Teboul JL. Prediction of fluid responsiveness. What's new? Ann Intensive Care. 2022 May 28;12(1):46. doi: 10.1186/s13613-022-01022-8.
PubMed 35633423
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Fluid Resuscitation on Capillary Refilling Time and Organ Functions in Septic Shock
- ClinicalTrials.gov ID
- NCT06067516
- Acronym / sponsor ID
- SUKAEK-2023 15/14
- Conditions
- Sepsis
- Keywords
- Sepsis, Fluid resuscitation, Capillary refill time, Sequential Organ Failure Assessment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Samsun UniversityUniversity, hospital or other
- Study start
- 25 Oct 2023 (actual)
- Primary completion
- 5 Jan 2026 (actual)
- Study completion
- 5 Jan 2026 (actual)
- First posted
- 5 Oct 2023 (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.
Since the ultimate target of resuscitation is the microcirculation, normal microcirculatory perfusion appears to be the primary target of ideal resuscitation in septic shock patients. In septic shock patients, microcirculation of the skin may be impaired in the early period due to early sympathetic nervous system activation.
Assessment of skin perfusion has also become popular in shock resuscitation because it is easily accessible for clinical assessment. Studies in septic shock patients, showed that capillary refill time correlated with lactate levels measured at 6 hours of resuscitation and was associated with mortality. Additionally, early normalization of capillary refill time has been associated with improved survival in septic shock This study aimed to evaluate the relationship between the change in capillary filling time (microcirculation) and organ perfusion after fluid resuscitation in sepsis patients in intensive care.
Detailed description
An aggressive approach to fluid resuscitation in patients with sepsis is recommended by international guidelines and is considered the cornerstone of treatment. This approach is based on historical concepts and the theory that septic shock is a form of hypovolemic shock characterized by tissue hypoperfusion.
Studies show that capillary refill time is a valuable method to measure the severity of acute disease both in the early and late stages. However, it remains unclear why abnormal peripheral perfusion increases morbidity and mortality. Because from a pathophysiological point of view, the main purpose of activation of the sympathetic nervous system is to maintain the perfusion of vital organs (brain, heart, lung).
The Sequential Organ Failure Assessment (SOFA) score is a simple and objective score that allows for calculation of both the number and the severity of organ dysfunction in six organ systems (respiratory, coagulatory, liver, cardiovascular, renal, and neurologic) and the score can measure individual or aggregate organ dysfunction.
This study aimed to evaluate the relationship between the change in capillary filling time (microcirculation) and SOFA score (organ perfusion) after fluid resuscitation in sepsis patients in intensive care.
After the first admission to the intensive care unit [T0 (baseline)], demographic information of the patients, source of sepsis, Sequential Organ Failure Assessment (SOFA) score, which shows the severity of the disease, Acute Physiology and Chronic Health Evaluation (APACHE II) score, additional systemic diseases, hemodynamic variables, blood gas parameters, and transthoracic echocardiogram findings will be recorded.
Capillary refill time (CRT) will be measured by applying pressure to the index finger for 15 seconds.
As recommended in the Surviving Sepsis Campaign Guidelines, after 30 mL/kg/3 hours crystalloid infusion (T1) and 24 hours (T2), Sequential Organ Failure Assessment (SOFA) score, hemodynamic variables, blood gas parameters, transthoracic echocardiogram findings and capillary refill time will be recorded again.
Patients will be divided into two groups; If the CRT measured at T1 decreased equal to or more than 25% compared to the CRT measured at T0, the patients as responders to capillary refill time (Group CRT-R); If the CRT measured at T1 decreased by less than 25% compared to the CRT measured at T0, the patients as non-responders to capillary refill time (Group CRT-NR) The effect of 30 mL/kg/3 hours crystalloid infusion on peripheral perfusion (in Group CRT-R and Group CRT-NR, which are divided into two by CRT measurement at T0 and T1 times) and the effect on the SOFA scores will be compared.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group CRT-R | – | Other: Fluid resuscitationsIf the CRT measured at T1 decreased equal to or more than 25% compared to the CRT measured at T0 |
| Group CRT-NR | – | Other: Fluid resuscitationsIf the CRT measured at T1 decreased by less than 25% compared to the CRT measured at T0 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to intensive care due to sepsis and septic shock.
Key inclusion criteria (8 listed)
- Over 18 years old
- Admitted to intensive care with a diagnosis of sepsis or septic shock
- Systolic blood pressure < 90 mmHg or Mean blood pressure < 65 mmHg
- Those who need vasopressor medication
- Urine output < 0.5 ml/kg/h for at least two hours
Key exclusion criteria (8 listed)
- Not approved by the patient or his/her guardian
- Known heart, kidney, liver failure
- The initial cause of shock is neurogenic, cardiogenic or obstructive shock.
- Pregnancy or suspected pregnancy
- Those with amputation or severe organ ischemia
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 |
|---|---|---|
| Fluid resuscitationsIn line with the recommendations in the Surviving Sepsis Guide, fingertip capillary refill time (CRT) will be measured by applying pressure to the index finger for 15 seconds in the T1 time period after 30 mL/kg/3 hours crystalloid infusion. | Other | Group CRT-NR, Group CRT-R |
Primary outcome
Sequential organ failure assessment score
Time frame: up to 24 hours
The sequential organ failure assessment score, previously known as the sepsis-related organ failure assessment score, is used to track a person's status during the stay in an intensive care unit to determine the extent of a person's organ function or rate of failure. The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems. Each organ system is assigned a point value from 0 (normal) to 4 (high degree of dysfunction/failure). Total the Sequential organ failure assessment score ranges from 0 to 24. The Sequential organ failure assessment score is 0 to 6: mortality < 10%, 7 to 9: mortality 5 - 20%. 10 to 12: mortality 40 - 50%, 13 to 14: mortality 50 - 60%, 15: mortality > 80%, 15 to 24: mortality > 90%. The sequential organ failure assessment score changes after fluid loading (normal value sequential organ failure assessment score < 2).
2 secondary outcomes
Stroke volume
Time frame: up to 24 hours
Cardiac output
Time frame: up to 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Background: PubMed 31420052Jacquet-Lagreze M, Bouhamri N, Portran P, Schweizer R, Baudin F, Lilot M, Fornier W, Fellahi JL. Capillary refill time variation induced by passive leg raising predicts capillary refill time response to volume expansion. Crit Care. 2019 Aug 16;23(1):281. doi: 10.1186/s13054-019-2560-0.
- Background: PubMed 29176794Lara B, Enberg L, Ortega M, Leon P, Kripper C, Aguilera P, Kattan E, Castro R, Bakker J, Hernandez G. Capillary refill time during fluid resuscitation in patients with sepsis-related hyperlactatemia at the emergency department is related to mortality. PLoS One. 2017 Nov 27;12(11):e0188548. doi: 10.1371/journal.pone.0188548. eCollection 2017.
- Background: PubMed 27481743Brunauer A, Kokofer A, Bataar O, Gradwohl-Matis I, Dankl D, Bakker J, Dunser MW. Changes in peripheral perfusion relate to visceral organ perfusion in early septic shock: A pilot study. J Crit Care. 2016 Oct;35:105-9. doi: 10.1016/j.jcrc.2016.05.007. Epub 2016 May 12.
- Background: PubMed 35633423Monnet X, Shi R, Teboul JL. Prediction of fluid responsiveness. What's new? Ann Intensive Care. 2022 May 28;12(1):46. doi: 10.1186/s13613-022-01022-8.
- 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.
OZGUR KOMURCU, 1 principal investigator
Samsun University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by Samsun University at 1 site in Turkey (Türkiye).
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 8 inclusion and 8 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 7 Jan 2026. 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 Turkey (Türkiye). 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?
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?
Sequential organ failure assessment score (time frame: up to 24 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 NCT06067516, 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 7 Jan 2026.