Microcirculation Recruitment Using Albumin 20% and Terlipressin in Septic Patients

NCT05080543 | Unknown Phase 1

• 1 other identifier: Microcirculation septic shock
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Septic Shock

Keywords

Microcirculation; Terlipressin; Human Albumin 20%

Outcome Measures

Primary Outcomes (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

  6 hrs

Secondary Outcomes (1)

• Mean Flow Index 24hs

  24 hs

Study Arms (2)

Group AT

ACTIVE COMPARATOR

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

Controlled

PLACEBO COMPARATOR

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

Interventions

Albumin 20% and terlipressin DRUG

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.

Also known as: Microcirculation

Controlled; Group AT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amany Mousa Salama Muhammed: lead

MeSH Terms

Conditions

Shock, Septic

Interventions

Albumins; Terlipressin; Microcirculation

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Proteins; Amino Acids, Peptides, and Proteins; Lypressin; Vasopressins; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Oligopeptides; Nerve Tissue Proteins; Blood Circulation; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Central Study Contacts

Amany Mousa Salama, Assistant lecturer

CONTACT

+201004820018; dr.amany.mousa@gmail.com

Mohamed Sayed Arafa, Lecturer

CONTACT

+201003752053; dr.3arafa1@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: CairoU

Model Details: a randomized controlled and double-blinded

Study Record Dates

• First Submitted: September 29, 2021
• First Posted: October 15, 2021
• Study Start: October 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: October 1, 2022
• Last Updated: October 15, 2021

Record last verified: 2021-10