Comparing the effect of albumin and crystalloid serum as resuscitation fluid in survival of patients with severe sepsis shock

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2016040316473N5

Enrollment

Registered

2016-07-06

Start date

2016-06-04

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Septic shock. Septic shock

Interventions

Intervention 1: In intervention group: fluid resuscitation with crystalloid serum plus 100 cc albumin 20% per 1 liter of crystalloid serum. Intervention 2: In control group: fluid resuscitation only w

Treatment - Drugs

In intervention group: fluid resuscitation with crystalloid serum plus 100 cc albumin 20% per 1 liter of crystalloid serum.

In control group: fluid resuscitation only with crystalloid serum.

Eligibility

Sex/Gender

All

Age

12 Years to 75 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: age between 12 to 75 years old; existence of at least two symptoms of SIRS syndrome (body temperature above 38 or below 36 ° C.; respiratory rate above 20 or PCO2 less than 32 or need for mechanical ventilation; heart rate more than 90, leukocytosis above 12,000 or leukopenia less than 4000 or band cells in peripheral blood smear); existence of a focal infection based on positive culture or existence of an obvious infected area such as peritonitis or pneumonia; need to resuscitation with fluid (tachycardia; systolic blood pressure less than 100 mm Hg or mean arterial pressure less than 75 mm Hg; urine volume less than 0.5 cc/kg/hr; need for vasopressor to maintain blood pressure; central venous pressure (CVP) less than 10 mm Hg). Exclusion criteria: brain death patients; patients undergoing plasmapheresis; contraindications of albumin infusion; heart failure or pulmonary failure or renal failure; transplant patients; patients with burns; heart surgery at 3 recent months.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Survival of patients. Timepoint: Daily for 28 days. Method of measurement: clinical examination.	—

Secondary

Measure	Time frame
Renal failure. Timepoint: Daily for 28 days. Method of measurement: Creatinine level.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Farzad Kakaei

Tabriz University of Medical Sciences.

Fkakaei@tbzmed.ac.ir+98 41 3334 1317

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026