CClinicalTrials.gg
Status unknownNCT04979273Updated Jul 28, 2021

The Role of Hypertonic Dextrose Spray as Endoscopic Topical Hemostatic Agent for Acute Non-Variceal Upper GI Bleeding

An interventional study of Dextrose 40 % in Water and Adrenaline 1 Mg/mL Solution for Injection in Gastro Intestinal Bleeding, sponsored by Dr Cipto Mangunkusumo General Hospital. Status unknown at 1 site in Indonesia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-07-28.

Sponsored by Dr Cipto Mangunkusumo General Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2021), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Mar 2021, registered Jul 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
66
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

This study is conducted to evaluate the effectivity of hypertonic dextrose spray as an endoscopic topical hemostatic agent, compared to conventional agent (adrenaline injection, followed by hemoclip or thermocoagulation), in patients with acute non-variceal upper GI bleeding.

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Conditions studied

  • Gastro Intestinal Bleeding
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In context

Gastrointestinal Hemorrhage

339 studies on the registry are indexed under Gastrointestinal Hemorrhage; 79 are open to participants now.

This study's planned enrollment of 66 is below the median of 87 across 211 interventional studies indexed under Gastrointestinal Hemorrhage.

Browse Gastrointestinal Hemorrhage studies →

Lead sponsor

Dr Cipto Mangunkusumo General Hospital is the lead sponsor of 37 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with acute non-variceal upper gastrointestinal bleeding caused by peptic or duodenal ulcer, polyps, tumors or malignancy
  • Patients consented to study participation

Exclusion criteria

Exclusion Criteria:

  • Patients with thrombocytopenia (thrombocyte count \<100.000 cells/ul) and other forms of coagulopathy
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
66 participants (estimated)

Study arms

  • Active comparator
    Control Group

    Patients within control group will be given adrenaline 1:20.000 injection, followed by thermocoagulation or hemoclip

    Drug: Adrenaline 1 Mg/mL Solution for Injection · Procedure: argon plasma coagulation · Procedure: Hemoclip

  • Experimental
    Dextrose group

    Patients within this group will be given adrenaline 1:20.000 injection, followed by dextrose 40% spray

    Drug: Dextrose 40 % in Water · Drug: Adrenaline 1 Mg/mL Solution for Injection

Interventions

  • DrugDextrose 40 % in Water

    injection of adrenaline 1:20.000, followed by dextrose 40% spray

  • DrugAdrenaline 1 Mg/mL Solution for Injection

    injection of adrenaline 1:20.000, followed by thermocoagulation or hemoclip

  • Procedureargon plasma coagulation

    Thermocoagulation

  • ProcedureHemoclip

    Hemoclip

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What researchers measure

Primary outcomes

  1. Hemostatic success

    Number of participants whose bleeding stops within five minutes after intervention is given. Outcome is assessed by independent assessor (not the endoscopy operator), who also attend the endoscopy session and could observe whether the bleeding stops.

    Time frame: 5 minute

Secondary outcomes

  1. Re-bleeding

    Number of participants who experience decrease in hemoglobin \>1g/dl or need additional hemostatic endoscopy within one week after intervention

    Time frame: 7 days

07

Study locations

1 of 1 sites recruiting
  • Dr. Cipto Mangunkusumo General Hospital
    Jakarta Pusat, DKI Jakarta 10430, Indonesia
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 28, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04979273
Lead sponsor
Dr Cipto Mangunkusumo General Hospital
Responsible party
Hasan Maulahela, MD (Head of Gastrointestinal Endoscopy Center FKUI-RSCM, Dr Cipto Mangunkusumo General Hospital) — Principal investigator
First posted
Jul 28, 2021
Start date
Mar 1, 2021
Primary completion
Dec 2021 (estimated)
Completion
Dec 2021 (estimated)
Last update
Jul 28, 2021

Study contacts

Hasan Maulahela, MD
Contact
hasanmaulahela@yahoo.com
+6281283602549
Hasan Maulahela, MD
principal investigator · Dr Cipto Mangunkusumo General Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.

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