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Microcirculation Recruitment Using Albumin 20% and Terlipressin in Septic Patients

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ClinicalTrials.gov Identifier: NCT05080543
Recruitment Status : Not yet recruiting
First Posted : October 15, 2021
Last Update Posted : October 15, 2021
Sponsor:
Information provided by (Responsible Party):
Amany Mousa Salama Muhammed, Cairo University

Brief 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.

Condition or disease Intervention/treatment Phase
Septic Shock Drug: Albumin 20% and terlipressin Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: a randomized controlled and double-blinded
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Recruitment of Microcirculation Using Albumin 20% and Terlipressin in Patients With Septic Shock: a Randomized Controlled Double-blinded Study.
Estimated Study Start Date : October 2021
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arm Intervention/treatment
Active Comparator: Group AT
will 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)
Drug: Albumin 20% and terlipressin
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.
Other Name: Microcirculation

Placebo Comparator: Controlled
will 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).
Drug: Albumin 20% and terlipressin
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.
Other Name: Microcirculation




Primary Outcome Measures :
  1. Mean Flow Index 6hs [ Time Frame: 6 hrs ]
    Determination the degree the mean flow index (MFI) 6 hrs after administration albumin and terlipressin in patient with septic shock


Secondary Outcome Measures :
  1. Mean Flow Index 24hs [ Time Frame: 24 hs ]
    Determination the degree the mean flow index (MFI) 24 hrs after administration albumin and terlipressin in patient with septic shock.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The presence of septic shock meeting all of the following criteria less than 24 hours:-

    1. Clinically possible or probable or microbiologically confirmed infection taking into account the definitions of the "International Sepsis Forum (ISF)"
    2. Despite adequate volume therapy, vasopressors are required to maintain mean arterial pressure (MAP) ≥ 65 mm Hg.
    3. Serum lactate level > 2 mmol/l (18 mg/dl) despite adequate volume therapy.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05080543


Contacts
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Contact: Amany Mousa Salama, Assistant lecturer +201004820018 dr.amany.mousa@gmail.com
Contact: Mohamed Sayed Arafa, Lecturer +201003752053 dr.3arafa1@gmail.com

Sponsors and Collaborators
Amany Mousa Salama Muhammed
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Responsible Party: Amany Mousa Salama Muhammed, CairoU, Cairo University
ClinicalTrials.gov Identifier: NCT05080543    
Other Study ID Numbers: Microcirculation septic shock
First Posted: October 15, 2021    Key Record Dates
Last Update Posted: October 15, 2021
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amany Mousa Salama Muhammed, Cairo University:
Microcirculation
Terlipressin
Human Albumin 20%
Additional relevant MeSH terms:
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Shock, Septic
Shock
Pathologic Processes
Sepsis
Infections
Systemic Inflammatory Response Syndrome
Inflammation
Terlipressin
Antihypertensive Agents
Vasoconstrictor Agents