To determine clinicoepidemiological characteristics and to evaluate the safety and effectiveness of Polygeline in patients with Hypovolemia

A Prospective, multicenter Observational Study to Determine the clinicoepidemiological profile of Indian Patients Presenting with Hypovolemia and to evaluate the Safety and effectiveness of Polygeline - NA

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2025/01/078960

Enrollment

165

Registered

2025-01-17

Start date

Unknown

Completion date

Unknown

Last updated

2025-06-24

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

Conditions

Health Condition 1: E861- Hypovolemia

Interventions

Intervention1: Polygeline 3.5% IV Infusion: Dose is 3.5%, duration is for 24 hours and route of administration is IV. Control Intervention1: NA: NA

Eligibility

Inclusion criteria

Inclusion criteria: The subjects will be included in the study based on the following criteria 1. Male and female patient’s =18 to 65 years of age. 2. Informed consent will be primarily obtained from patient’s Legally Acceptable Representative (LAR) or patient themselves when they could give consent. 3. Adult patients who present with symptoms of hypovolemia and who have been prescribed IV Polygeline as per the discretion of the investigator will be included in the study. 4. Patients presenting with Class II or III of hypovolemia due to hemorrhage (per Advanced Trauma Life Support criteria of acute hemorrhage).

Exclusion criteria

Exclusion criteria: The subject will be excluded from the study if they meet any of the following criteria: 1. Patients with hypersensitivity to Polygeline or any other constituent. 2. Pregnant and breast-feeding women, patients with concomitant asthma and unconscious patients. 3. Patients who are critically ill, as per the discretion of the investigator. 4. Patients who have been given Hydroxyethyl starch (HES), Albumin, other gelatins (gelofusine) or any other kind of synthetic colloid.

Design outcomes

Primary

Measure	Time frame
1.Demographic profile - Age, gender, education and occupation. 2.Clinico-epidemiological – Classification of hypovolemia, volume of blood loss, cause of hypovolemia. Timepoint: 24 Hrs	—

Secondary

Measure	Time frame
To determine effectiveness A. Change from baseline at every hour till 6 hrs. and then at 10 hrs., 14 hrs., 18 hrs. and 24 hrs. 1. Blood pressure – Systolic, Diastolic and mean arterial 2. Respiratory rate 3. Pulse rate 4. Urine output 5. Pallor and condition of skin (cold, clammy) B. Change from baseline at 12 hrs. and 24 hrs. for the following parameters: 1. Arterial pH 2. Bicarbonate levels 3. Blood lactate 4. Anion Gap Timepoint: 24Hrs	—

Measure

Time frame

To determine effectiveness A. Change from baseline at every hour till 6 hrs. and then at 10 hrs., 14 hrs., 18 hrs. and 24 hrs. 1. Blood pressure – Systolic, Diastolic and mean arterial 2. Respiratory rate 3. Pulse rate 4. Urine output 5. Pallor and condition of skin (cold, clammy) B. Change from baseline at 12 hrs. and 24 hrs. for the following parameters: 1. Arterial pH 2. Bicarbonate levels 3. Blood lactate 4. Anion Gap Timepoint: 24Hrs

—

Countries

India

Contacts

Public ContactDr Shivani Acharya

Abbott Healthcare Private Limited,

kartik.peethambaran@abbott.com8454041733

Outcome results

None listed

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