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Septic ShockPhase 1NCT05080543

Microcirculation Recruitment Using Albumin 20% and Terlipressin in Septic Patients

A Phase 1 study testing Albumin 20% and terlipressin in people with Septic Shock, run by Amany Mousa Salama Muhammed.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The aim of this study is to evaluate the effect of combining HSA 20% and terlipressin on the microcirculation in patients with septic shock using the following;- Microcirculation recruitment by Cytocam-IDF. Cardiac output by LiDCOrapid. Measuring serum lactate level. 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?
Albumin 20% and terlipressin
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
36 participants
Where
No sites listed yet
Study dates
Oct 2021to Oct 2022
Phase
Phase 1
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

  • The presence of septic shock meeting all of the following criteria less than 24 hours:-
  • Clinically possible or probable or microbiologically confirmed infection taking into account the definitions of the "International Sepsis Forum (ISF)"
  • Despite adequate volume therapy, vasopressors are required to maintain mean arterial pressure (MAP) ≥ 65 mm Hg.
  • Serum lactate level > 2 mmol/l (18 mg/dl) despite adequate volume therapy.

Who cannot join

  • Patients who failed to achieve target MAP despite adequate resuscitation with fluids and maximum dose of noreadrenaline.
  • Acute coronary artery disease or underlying cardiac dysfunction [cardiac index (CI) <2.2 l/min/m 2 ].
  • Severe liver disease (Child-Pugh grade C)
  • Chronic renal failure.
  • Known hypersensitivity to Norepinephrine, terlipressin and human albumin.
  • Those having Raynaud's phenomenon, or a vasospastic diathesis and
  • Other causes of shock e.g.; hemorrhagic hypovolaemia, cardiogenic shock, anaphylactic shock, neurogenic shock.
  • Pregnant patients and lactation.

Trial locations and contacts

No sites are listed yet.

Amany Mousa Salama, Assistant lecturer contact

+201004820018

dr.amany.mousa@gmail.com

Mohamed Sayed Arafa, Lecturer contact

+201003752053

dr.3arafa1@gmail.com

About this study

Official title: Recruitment of Microcirculation Using Albumin 20% and Terlipressin in Patients With Septic Shock: a Randomized Controlled Double-blinded Study.

The aim of this study is to evaluate the effect of combining HSA 20% and terlipressin on the microcirculation in patients with septic shock using the following;-

  • Microcirculation recruitment by Cytocam-IDF.
  • Cardiac output by LiDCOrapid.
  • Measuring serum lactate level.
Read the detailed description

Sepsis is one of the major medical problems and is responsible for high morbidity and mortality. Surviving Sepsis Campaign Guideline 2016 introduced 3-hours and 6-hours bundles in management of septic shock. The 2018 update of the Surviving Sepsis Campaign guidelines introduced the 'Hour-1 Bundle' which recommends treatment with intravenous fluids, measurement of serum lactate concentration as a marker of illness severity, administration of vasopressors, obtaining blood cultures and administering broad-spectrum antibiotics, all within the first hour.

The usual targets for resuscitation of patients with septic shock are the macro-circulatory parameters such as mean arterial blood pressure and heart rate; however, it is believed that restoration of microcirculatory parameters is not sufficient to avoid organ failure unless it was associated with improved microcirculatory perfusion. The loss of coherence between macro- and micro-circulatory parameters increases the need to evaluate the microcirculatory blood flow. So impaired microvascular perfusion is increasingly recognized as a major determinant of tissue hypoxia during sepsis and is a key factor in the pathogenesis of sepsis-induced organ failure.

Fluid resuscitation is recommended to be initiated immediately and completed within the first hour. Guidelines recommend at least a 30-mL/kg bolus of crystalloid fluid as the initial resuscitation. Crystalloid is the fluid of choice for initial resuscitation and subsequent intra-vascular volume replacement in patients with sepsis and septic shock.

Albumin in addition to crystalloids is suggested when patients require a substantial amount of crystalloids. Although the guidelines make no recommendation regarding which concentration of albumin should be used, 5% albumin is most commonly used in patients with hypovolemia to administer as much volume as possible.

In 2016, a study showed that in a rat model of normotensive endotoxemia, the infusion of 4% or 20% Human Serum Albumin "HSA" restored microvascular perfusion in otherwise unresuscitated animals. A more stable microvascular improvement noticed with 20% HSA.

Sepsis is also characterized by an enhanced activation of inflammatory and oxidative stress pathways, which leads to endothelial dysfunction and vascular hyporeactivity.

For its ability to counteract oxidative and nitrosative stress, albumin may represent not only a plasma expander but also an endothelium-modulating agent. In an experimental rodent model of endotoxemia, (HSA) prevented endothelial dysfunction and vascular hyporeactivity.

In patients with septic shock requiring vasopressors, a targeted mean arterial pressure "MAP" of 65 mm Hg within the first hour is recommended. Norepinephrine is the recommended first-line vasopressor in septic shock. If MAP is not maintained at 65 mm Hg or greater with norepinephrine alone or if the norepinephrine dose needs to be decreased, either vasopressin (up to 0.03 unit/minute) or epinephrine can be added to norepinephrine. Although norepinephrine is widely regarded as the first-line vasoactive medication in sepsis, literature continues to debate whether the early addition of vasopressin should be common practice.

Terlipressin is a synthetic analogue of vasopressin which has greater selectivity for the V1 receptor that cause vascular smooth muscle vasoconstriction in response to vasopressin and thus could be associated with fewer side effects than vasopressin.

In 2016 a study showed that terlipressin therapy was associated with good improvement in hemodynamic variables and kidney functions more than adrenaline in patients with refractory septic shock despite adequate fluid resuscitation and the use of norepinephrine.

No data was found on effect of combination of albumin and terlipressin on microcirculation in septic patients.

This study aims to investigate the effect of this combination on microcirculation using Cytocam-IDF (incident dark-field illumination), Braedius.

Conditions
Septic Shock
Being tested
Albumin 20% and terlipressin
Keywords
Microcirculation, Terlipressin, Human Albumin 20%
Medical subject headings
Shock, Septic

What participants receive

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

  • Albumin 20% and terlipressinDrug

    Also called Microcirculation

    Evaluation the effect of adding 20% HSA and terlipressin on microvascular flow index (MFI), flow heterogeneity index, total vessel density (TVD), and perfused vessel density (PVD) in comparison to the standard care in patient with septic shock.

Study groups in NCT05080543
Study groupRoleWhat they receive
Group ATActive comparatorwill receive a bolus of albumin (1gm/kg) and terlipressin loading dose of 1 mg over 20 minutes followed by infusion at rate (2 μ g/kg/h)
Receives: Drug: Albumin 20% and terlipressin
ControlledPlacebo comparatorwill receive the routine management of septic shock patients as culture-based IV antibiotics, IV fluids and intropic support plus a placebo (as lactated ringer solution in the same infusion rates for blinding).
Receives: Drug: Albumin 20% and terlipressin

What is being measured

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

  1. Mean Flow Index 6hs

    Determination the degree the mean flow index (MFI) 6 hrs after administration albumin and terlipressin in patient with septic shock

    Measured: 6 hrs

Secondary outcomes (1)
  1. Mean Flow Index 24hs

    Determination the degree the mean flow index (MFI) 24 hrs after administration albumin and terlipressin in patient with septic shock.

    Measured: 24 hs

Timeline

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

  1. First posted15 Oct 2021
  2. Study startOct 2021 (estimated)
  3. Primary completionSep 2022 (estimated)
  4. Study completionOct 2022 (estimated)

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 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
a randomized controlled and double-blinded
Masking
Single blind
Who is masked
Investigator
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05080543
Sponsor's protocol ID
Microcirculation septic shock
Status last verified
Oct 2021
First submitted
29 Sep 2021
Last updated
15 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Albumin 20% and terlipressin in people with Septic Shock, run by Amany Mousa Salama Muhammed.

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 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: status not confirmed, as of the sponsor's last update on 15 Oct 2021. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Amany Mousa Salama, Assistant lecturer (+201004820018, dr.amany.mousa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Flow Index 6hs (time frame: 6 hrs). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 15 Oct 2021.

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